Harold Bays MD, FOMA, FTOS, FACC, FNLA, FASPC

CLINICAL TRIALS & PUBLICATIONS

Harold Bays MD, FOMA, FTOS, FACC, FACE, FNLA, FASPC

Dr. Harold Bays is Medical Director and President of the Louisville Metabolic and Atherosclerosis Research Center, Inc. (L-MARC), as well as Your Body Goal. He has served as a Principal Investigator for over 600 clinical trials of metabolic therapeutic interventions. Dr. Bays is Board Certified in Internal Medicine and Endocrinology and Metabolism, Diplomate of the American Board of Obesity Medicine, and a Diplomate of the American Board of Clinical Lipidology. He is a Fellow of the Obesity Medicine Association, The Obesity Society, the American College of Cardiology, the American Association of Clinical Endocrinologists, the National Lipid Association, and the American Society of Preventive Cardiology. Dr. Bays has written or served as a contributing author to over 350 scientific manuscripts and book chapters and authored/presented 100’s of scientific abstracts. He has served as a Board of Director and Executive Officer of Scientific Organizations, served as the Chairman for many scientific projects, and authored a number of Scientific Consensus and Clinical Practice Statements and National Recommendations. Dr. Bays is the Chief Science Officer for the Obesity Medicine Association, member of the Board of Trustees of the Obesity Medicine Association, and is Editor-in-Chief of Obesity Pillars (official journal of the Obesity Medicine Association). Among his awards include the 2015 National Lipid Association “President’s Service Award” and the 2016 Obesity Medicine Association “Obesity Medicine Clinician of the Year.”

Harold Bays MD

Academia and More

Below are examples of some publications and clinical trials

Publications

Click on the links below for publications Dr. Bays has authored:

Curriculum Vitae

HAROLD BAYS MD CURRICULUM VITAE 2023

Clinical Trials

CLINICAL TRIALS

Disease-state clinical trials Harold Bays MD has served as an Investigator:

Click on any of the below

Obesity

A phase 2 randomized, placebo-controlled, double-blind dose-ranging study to evaluate the efficacy, safety and tolerability of AMG 133 in adult subjects with overweight and obesity, with or without type 2 diabetes mellitus
(PRINCIPAL INVESTIGATOR, 2023)

A phase 3b, randomized controlled study to evaluate the efficacy and safety of tirzepatide compared to semaglutide 2.4mg in adults who have obesity or overweight with weight-related comorbidities (SURMOUNT-5)
(PRINCIPAL INVESTIGATOR, 2023)

A phase 2, multi-center, randomized, double-blind, dose-ranging, placebo-controlled study to assess the safety and efficacy of S-309309 in Obese Adults
(PRINCIPAL INVESTIGATOR, 2023)

A phase 2 randomized, double-blind, placebo-controlled, 13-week dose finding study of VK2735 for weight management in subjects who are obese, or overweight with at least one weight-related comorbid condition
(PRINCIPAL INVESTIGATOR, 2023)

A randomized, placebo-controlled, double-blind 13-week study to evaluate the safety, tolerability, and weight loss efficacy of K-757 alone and in combination with K-833 in participants who are obese
(PRINCIPAL INVESTIGATOR, 2023)

A phase 3b, randomized controlled study to evaluate the efficacy and safety of tirzepatide once weekly 5mg and/or maximum tolerated dose versus placebo for maintenance of body weight reduction in participants who have obesity or overweight with weight-related comorbidities (SURMOUNT-MAINTAIN)
(PRINCIPAL INVESTIGATOR, 2023)

A phase 3, randomized, double-blind, parallel-group, 76-week, efficacy and safety study of BI456906 administered subcutaneously compared with placebo in participantswith overweight or obesity without type 2 diabetes (SYNCHRONIZE-1)
(PRINCIPAL INVESTIGATOR, 2023)

A phase 2, multicenter, randomized, double-blind, placebo-controlled and parallel group 48-week study to evaluate the efficacy and safety of ALT-801 in the treatment of obesity
(PRINICIPAL INVESTIGATOR, 2022)

A phase 3 randomized, double-blind, placebo-controlled study to investigate the effects of tirzepatide on the reduction of morbidity and mortality in adults with obesity
(PRINCIPAL INVESTIGATOR, 2022)

A multicenter, randomized, double-blind study to compare the effects of VI-0521, Phentermine, and Placebo on Ambulatory Blood pressure in Overweight or Obese subjects
(PRINCIPAL INVESTIGATOR, 2022)

EFFICACY AND SAFETY OF TIRZEPATIDE ONCE WEEKLY VERSUS PLACEBO FOR MAINTENANCE OF WEIGHT LOSS IN PARTICIPANTS WITHOUT TYPE 2 DIABETES WHO HAVE OBESITY OR ARE OVERWEIGHT WITH WEIGHT-RELATED COMORBIDITIES: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL (SURMOUNT-4)
(PRINCIPAL INVESTIGATOR, 2021)

INVESTIGATION OF EFFICACY AND SAFETY OF NNC0165-1875 AS ADD-ON TO SEMAGLUTIDE FOR WEIGHT MANAGEMENT IN SUBJECTS WITH OBESITY
(PRINCIPAL INVESTIGATOR, 2021)

EFFECT OF SUBCUTANEOUS SEMAGLUTIDE 2.4 MG ONCE-WEEKLY COMPARED TO PLACEBO IN SUBJECTS WITH OBESITY AND KNEE OSTEOARTHRITIS
(PRINCIPAL INVESTIGATOR, 2021)

SELECT-LIFE (SELECT FOLLOW-UP STUDY TO EVALUATE LONGTERM IMPACT OF ANTI-OBESITY MEDICATION
(PRINCIPAL INVESTIGATOR, 2021)

PATIENT CONCEPT ELICITATION INTERVIEWS IN SUPPORT OF AMGEN OBESITY PORTFOLIO
(PRINCIPAL INVESTIGATOR, 2021)

A 26-WEEK, PHASE 2B, 2-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06882961 ADMINISTRATION IN ADULTS WITH OBESITY
(PRINCIPAL INVESTIGATOR, 2020)

THE EFFECT OF EPITOMEE CAPSULE ON BODY WEIGHT IN PATIENTS WITH OVERWEIGHT AND OBESITY WITH AND WITHOUT PREDIABETES
(PRINCIPAL INVESTIGATOR, 2020)

A PHASE II, RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, 46 WEEKS DOSE-FINDING STUDY OF BI 456906 ADMINISTERED ONCE WEEKLY SUBCUTANEOUSLY COMPARED WITH PLACEBO IN PATIENTS WITH OBESITY OR OVERWEIGHT
(PRINCIPAL INVESTIGATOR, 2019)

SELECT – SEMAGLUTIDE EFFECTS ON CARDIOVASCULAR OUTCOMES IN PEOPLE WITH OVERWEIGHT OR OBESITY
(PRINCIPAL INVESTIGATOR, 2019)

EFFICACY AND SAFETY OF TIRZEPATIDE ONCE WEEKLY IN PARTICIPANTS WITHOUT TYPE 2 DIABETES WHO HAVE OBESITY OR ARE OVERWEIGHT WITH WEIGHT-RELATED COMORBIDITIES: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL (SURMOUNT-1)
(PRINCIPAL INVESTIGATOR, 2019)

A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED AND OPEN-LABEL ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE SAFETY AND EFFICACY OF JNJ-64565111 IN NON-DIABETIC OBESE SUBJECTS
(PRINCIPAL INVESTIGATOR, 2018)

EFFECT AND SAFETY OF SEMAGLUTIDE 2.4 MG ONCE-WEEKLY IN SUBJECTS WITH OVERWEIGHT OR OBESITY WHO HAVE REACHED TARGET DOSE DURING RUN-IN PERIOD
(PRINCIPAL INVESTIGATOR, 2018)

EFFECT AND SAFETY OF SEMAGLUTIDE 2.4MG ONCE-WEEKLY IN SUBJECTS WITH OVERWEIGHT OR OBESITY
(PRINCIPAL INVESTIGATOR, 2018)

A RANDOMIZED, DOUBLE-BLIND, DOSE-FINDING STUDY TO EVALUATE THE CHANGE IN WEIGHT AFTER 24 WEEKS OF TREATMENT WITH 8 DOSES OF LIK066 COMPARED TO PLACEBO IN OBESE OR OVERWEIGHT ADULTS, FOLLOWED BY 24 WEEKS TREATMENT WITH 2 DOSES OF LIK066 AND PLACEBO
(PRINCIPAL -INVESTIGATOR, 2017)

EFFECT AND SAFETY OF LIRGLUTIDE 3.0 MG IN SUBJECTS WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES MELLITUS TREATED WITH BASAL INSULIN
(PRINCIPAL INVESTIGATOR, 2016)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFECT OF LONG-TERM TREATMENT WITH BELVIQ (LORCASERIN HCL) ON THE INCIDENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS AND CONVERSION TO TYPE 2 DIABETES MELLITUS IN OBESE AND OVERWEIGHT SUBJECTS WITH CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS
(PRINCIPAL INVESTIGATOR, 2014)

A 20 WEEK, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP TRIAL TO ASSESS THE EFFICACY AND SAFETY OF HM11260C ON BODY WEIGHT IN OBESE SUBJECTS WITHOUT DIABETES
(PRINCIPAL INVESTIGATOR, 2014)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF THE CO-ADMINISTRATION OF CANAGLIFLOZIN 300MG AND PHENTERMINE 15 MG WITH PLACEBO FOR THE TREATMENT OF NON-DIABETIC OVERWEIGHT AND OBESE SUBJECTS
(PRINCIPAL INVESTIGATOR, 2013)

A PHASE 1, PLACEBO-CONTROLLED, RANDOMIZED TRIAL TO ACCESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE IV DOSES OF PF-05231023 IN OBESE HYPERLIPIDEMIC ADULT SUBJECTS WITH AND WITHOUT TYPE 2 DIABETES MELLITUS ON A BACKGROUND OF ATORVASTATIN
(PRINCIPAL INVESTIGATOR, 2013)

A 26 WEEK RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VARIOUS DOSES OF HPP404 ON WEIGHT LOSS IN OVERWEIGHT OR OBESE SUBJECTS
(PRINCIPAL INVESTIGATOR, 2012)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY ASSESSING THE OCCUREENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) IN OVERWEIGHT AND OBESE SUBJECTS WITH CARDIOVASCULAR RISK FACTORS RECEIVING NALTREXONE SR/BUPROPION SR
(PRINCIPAL INVESTIGATOR, 2011)

EFFECT OF LIRAGLUTIDE ON BODY WEIGHT IN OVERWEIGHT OR OBESE SUBJECTS WITH TYPE 2 DIABETES: A 56 WEEK RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE ARMED PARALLEL GROUP, MULTICENTRE, MULTINATIONAL TRIAL WITH A 12 WEEK OBSERVATIONAL FOLLOW-UP PERIOD
(PRINCIPAL INVESTIGATOR, 2011)

A 26- WEEK, RANDOMISED, CONTROLLED, OPEN LABEL, MULTICENTRE, MULTINATIONAL, TREAT TO TARGET TRIAL INVESTIGATING THE IMPACT OF DIETARY INTERVENTION ON WEIGHT CHANGE AND THE RELATIONSHIP BETWEEN WEIGHT CHANGE AND BASELINE BODY MASS INDEX (BMI) IN SUBJECTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED ON ORAL ANTIDIABETIC DRUGS (OADS) INITIATION INSULIN THERAPY WITH INSULIN DETEMIR IN COMBINAITON WITH METFORMIN
PRINCIPLE INVESTIGATOR (2010)

DOUBLE-BLIND, MULTI-CENTER, RANDOMIZED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF 400 MG OF VELNEPERIT (S-2367) AND 120 MG OF ORLISTAT ADMINISTERED INDIVIDUALLY OR COMBINED ORALLY THREE TIMES PER DAY WITH A REDUCED CALORIE DIET (RCD) IN OBESE SUBJECTS
PRINCIPLE INVESTIGATOR (2010)

A DOUBLE-BLIND, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, 16 WEEK STUDY OF 0, 400, OR 1600 MG/DAY S-2367 ADMINISTERED ORALLY ONCE-A-DAY WITH OR WITHOUT A LOW CALORIE DIET LEAD-IN IN OBESE MALES AND FEMALES
PRINCIPLE INVESTIGATOR (2010)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF JNJ-28431754 IN NONDIABETIC OVERWEIGHT AND OBESE SUBJECTS
PRINCIPAL INVESTIGATOR (2008)

A MULTICENTER, RANDOMIZED, PARALLEL-GROUP, PLACEBO-CONTROLLED, EFFICACY AND SAFETY TRIAL TO EVALUATE THE EFFECT OF SCH 497079 ON WEIGHT IN OBESE AND OVERWEIGHT SUBJECTS
PRINCIPAL INVESTIGATOR (2008)

EFFECT OF LIRAGLUTIDE ON LONG-TERM WEIGHT MAINTENANCE FOLLOWING WEIGHT LOSS INDUCED BY A 12 WEEK LOW CALORIE DIET IN OBESE SUBJECTS; A 52 WEEK RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE TRIAL WITH A 12 WEEK FOLLOW-UP PERIOD.
PRINCIPAL INVESTIGATOR (2008)

DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, 12-WEEK STUDY OF THE SAFETY AND EFFICACY OF ATHX-105 PHOSPHATE FOR THE TREATMENT OF OBESITY
PRINCIPAL INVESTIGATOR (2008)

A MULTICENTER RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF MBX-8025 IN MODERATELY OBESE HYPERLIPIDEMIC PATIENTS WITH OR WITHOUT CONCOMITANT ATORVASTATIN.
PRINCIPAL INVESTIGATOR (2007)

A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED MULTICENTER STUDY TO DETERMINE THE SAFETY AND EFFICACY OF VI-0521 IN THE TREATMENT OF OBESITY IN ADULTS WITH OBESITY-RELATED CO-MORBID CONDITIONS
(PRINCIAL INVESTIGATOR (2007)

A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY TO DETERMINE THE SAFETY AND EFFICACY OF V1-0521 IN THE TREATMENT OF OBESITY IN AN ADULT POPULATION WITH BMI ≥35
PRINCIPAL INVESTIGATOR (2007)

52-WEEK, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF LORCASERIN HYDROCHLORIDE IN OVERWEIGHT AND OBESE PATIENTS WITH TYPE 2 DIABETES MELLITUS MANAGED WITH ORAL HYPOGLYCEMIC AGENT(S) [BLOOM-DM: BEHAVIORAL MODIFICATION AND LORCASERIN FOR OVERWEIGHT AND OBESITY MANAGEMENT IN DIABETES MELLITUS.]
PRINCIPAL INVESTIGATOR (2007)

A 52-WEEK, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF LORCASERIN HYDROCHLORIDE IN OVERWEIGHT AND OBESE PATIENTS. [BLOSSOM: BEHAVIORAL MODIFICATION AND LORCASERIN SECOND STUDY FOR OBESITY MANAGEMENT]
PRINCIPAL INVESTIGATOR (2007)

A MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY COMPARING THE SAFETY AND EFFICACY OF NALTREXONE 32MG SUSTAINED RELEASE (SR)/BUPROPION 360MG SUSTAINED RELEASE (SR) AND PLACEBO IN OBESE SUBJECTS WITH TYPE 2 DIABETES MELLITUS
PRINCIPAL INVESTIGATOR (2007)

A RANDOMIZED, PARALLEL-GROUP, MULTICENTER STUDY TO EXAMINE THE SAFETY, TOLERABILITY, AND BODY WEIGHT EFFECT OF SUBCUTANEOUS PRAMLINTIDE ALONE AND IN COMBINATION WITH THE ORAL ANTIOBESITY AGENTS SIBUTRAMINE AND PHENTERMINE IN OVERWEIGHT AND OBESE SUBJECTS.

PRINCIPAL INVESTIGATOR (2007)

A PHASE IIB/III RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF MK-0364 IN OBESE PATIENTS AND IN OVERWEIGHT PATIENTS WITH OBESITY-RELATED CO-MORBIDITIES, FOLLOWED BY A 1-YEAR EXTENSION
PRINCIPAL INVESTIGATOR (2007)

A RANDOMIZE, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EXAMINE THE EFFECT OF BETAHISTINE ON BODY WEIGHT IN OBESE SUBJECTS
PRINCIPAL INVESTIGATOR (2006)

A DOUBLE-BLIND, RANDOMIZED, PARALLEL, EFFICACY STUDY EVALUATING LOSARTAN POTASSIUM ALONE OR IN COMBINATION WITH HYDROCHLOROTHIAZIDE VERSUS PLACEBO IN OBESE PATIENTS WITH ELEVATED SYSTOLIC AND DIASTOLIC BLOOD PRESSURE
PRINCIPAL INVESTIGATOR (2006)

A 2-YEAR STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF MK-0364 IN OBESE PATIENTS
PRINCIPAL INVESTIGATOR (2006)

AN 18-MONTH STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF MK-0364 IN OBESE PATIENTS.
PRINCIPAL INVESTIGATOR (2006)

BEHAVIORAL MODIFICATION AND LORCASERIN SECOND STUDY FOR OBESITY MANAGEMENT (BLOOM). A 104 WEEK, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY LORCASERIN HYDROCHLORIDE IN OBESE PATIENTS
PRINCIPAL INVESTIGATOR (2006)

OPEN-LABEL EXTENSION OF INITIAL 16-WEEK PROOF-OF-CONCEPT STUDY TO CONTINUE ADMINISTRATION OF S-2367 ORALLY ONCE-A-DAY FOR 12 ADDITIONAL MONTHS (IE, 52 WEEKS) IN OBESE MALES AND FEMALES.
PRINCIPAL INVESTIGATOR (2006)

A 2-YEAR, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF CP-945,598 IN THE TREATMENT OF OBESE SUBJECTS
PRINCIPAL INVESTIGATOR (2006)

OPEN-LABEL EXTENSION OF INITIAL 16-WEEK PROOF-OF-CONCEPT STUDY TO CONTINUE ADMINISTRATION OF S-2367 ORALLY ONCE-A-DAY FOR 6 ADDITIONAL MONTHS IN OBESE MALES AND FEMALES.
PRINCIPAL INVESTIGATOR (2006)

A 6-MONTH, RANDOMIZED, DOUBLE-BLIND, PLACEBO AND POSITIVE-CONTROLLED PHASE 2B STUDY TO EVALUATE THE EFFECT OF VARIOUS DOSES OF CP-945,598 ON WEIGHT LOSS IN OBESE SUBJECTS
PRINCIPAL INVESTIGATOR (2005)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND EFFICACY OF L-000328495 IN OBESE PATIENTS
PRINCIPAL INVESTIGATOR (2005)

AN 18 MONTH STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF L-000899055 IN OBESE PATIENTS
PRINCIPAL INVESTIGATOR (2005)

A 2 YEAR STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF L-000899055 IN OBESE PATIENTS
PRINCIPAL INVESTIGATOR (2005)

A 12-WEEK, DOSE-RANGING, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF APD356 IN OBESE PATIENTS
PRINCIPAL INVESTIGATOR (2005)

DOUBLE-BLIND, MULTI-CENTER, RANDOMIZED, PARALLEL-GROUP, 16 WEEK STUDY OF 0, 400, OR 1600 MG/DAY S-2367 ADMINISTERED ORALLY ONCE-A-DAY WITH OR WITHOUT A LOW CALORIE DIET LEAD-IN IN OBESE MALES AND FEMALES
PRINCIPAL INVESTIGATOR (2005)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF L-000414380 MONOTHERAPY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND METABOLIC SYNDROME
PRINCIPAL INVESTIGATOR (2004)

A 6-MONTH, RANDOMIZED STUDY TO EVALUATE THE EFFICACY OF VARIOUS NON-PHARMACOLOGIC, DISEASE MANAGEMENT PROGRAMS FOR THE TREATMENT OF OBESITY
PRINCIPAL INVESTIGATOR (2004)

A STUDY TO ASSESS THE SAFETY AND EFFICACY OF L-000899055 IN OBESE PATIENTS
PRINCIPAL INVESTIGATOR (2004)

A DOUBLE-BLIND, RANDOMZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND EFFICACY OF MK-0557 IN COMBINATION WITH SIBUTRAMINE OR ORLISTAT IN OBESE SUBJECTS
PRINCIPAL INVESTIGATOR (2004)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND EFFICACY OF L-000753721 IN OBESE PATIENTS
PRINCIPAL INVESTIGATOR (2003)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND EFFICACY OF L-000753721 IN MAINTAINING WEIGHT LOSS INDUCED BY A VERY LOW CALORIE DIET IN OBESE PATIENTS
PRINCIPAL INVESTIGATOR (2003)

A DOSE RANGE FINDING DOUBLE-BLIND, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND AND EFFICACY OF L-753721 IN OBESE SUBJECTS
PRINCIPAL INVESTIGATOR (2002)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, SHORT-TERM SAFETY AND EFFICACY STUDY OF TWO DOSES OF AXOKINE IN OVERWEIGHT AND OBESE PATIENTS WITH TYPE 2 DIABETES MELLITUS - EXTENSION
PRINCIPAL INVESTIGATOR (2002)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, FIXED DOSE, MULTICENTER STUDY OF WEIGHT-REDUCING AND PREVEVENTION OF WEIGHT REGAIN EFFECTS AND SAFETY OF SR141716 IN OBESE PATIENTS WITH OR WITHOUT COMORBIDITIES
PRINCIPAL INVESTIGATOR (2001)

A PHASE III, 12 MONTH, DOUBLE BLIND, RANDOMIZED, PARALLEL GROUP, PLACEBO CONTROLLED, EFFICACY AND SAFETY STUDY OF AXOKINE IN OVERWEIGHT AND OBESE SUBJECTS WITH A 12 MONTH OPEN-LABEL EXTENSION PHASE
PRINCIPAL INVESTIGATOR (2001)

RESEARCH COMPLETED TRIALS A 52 WEEK, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY OF ORLISTAT TREATMENT IN OBESE PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED WITH INSULIN
PRINCIPAL INVESTIGATOR (1998)

Diabetes

Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesity and type 2 diabetes
(PRINCIPAL INVESTIGATOR, 2023)

A phase 3, open-label, study of once-daily LY3502970 compared with insulin glargine in adult participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk (achieve-4)
(PRINCIPAL INVESTIGATOR, 2023)

A phase 3, randomized, double-blind, parallel-group, 76-week, efficacy and safety study of BI456906 administered subcutaneously compared with placebo in participants with overweight and obesity and type 2 diabetes mellitus (SYNCHRONIZE-2)
(PRINCIPAL INVESTIGATOR, 2023)

A PHASE 3, MULTICENTER, RANDOMIZED, PARALLEL-DESIGN, OPEN-LABEL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LY3209590 COMPARED WITH INSULIN DEGLUDEC IN PARTICIPANTS WITH TYPE 2 DIABETES CURRENTLY TREATED WITH BASAL INSULIN (QWINT-3)
(PRINCIPAL INVESTIGATOR, 2022)

EFFICACY AND SAFETY OF ONCE-DAILY ORAL SEMAGLUTIDE 25MG AND 50MG COMPARED WITH 14MG IN SUBJECTS WITH TYPE 2 DIABETES.
(PRINCIPAL INVESTIGATOR, 2021)

A PHASE 2, PARALLEL, COMPARATOR-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF LY3209590 IN INSULIN NAÏVE PATIENTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2020)

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO- AND COMPARATOR-CONTROLLED STUDY TO COMPARE THE GLYCEMIC EFFECTS, SAFETY, AND TOLERABILITY OF METFORMIN HYDROCHLORIDE DELAYED-RELEASE TABLETS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING RENAL FUNCTION FROM NORMAL UP TO CKD3B
(PRINCIPAL INVESTIGATOR, 2020)

A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PROOF OF CONCEPT STUDY OF VASCULAR ENDOTHELIAL GROWTH FACTOR (VEGF)-B BLOCKAGE WITH THE MONOCLONAL ANTIBODY CSL346 IN SUBJECTS WITH DIABETIC KIDNEY DISEASE
(PRINCIPAL INVESTIGATOR, 2020)

THE EFFECT OF TIRZEPATIDE VERSUS DULAGLUTIDE ON MAJOR ADVERSE CARDIOVASCULAR EVENTS IN PATIENTS WITH TYPE 2 DIABETES (SURPASS-CVOT)
(PRINCIPAL INVESTIGATOR, 2020)

QUALITATIVE STUDY TO EXAMINE PATIENT PERSPECTIVES OF SIMPLICITY AND COMPLEXITY OF TREATMENT FOR TYPE 2 DIABETES
(PRINCIPAL INVESTIGATOR, 2020)

SEMAGLUTIDE CARDIOVASCULAR OUTCOMES TRIAL IN PATIENTS WITH TYPE 2 DIABETES (SOUL)
(PRINCIPAL INVESTIGATOR, 2019)

EFFICACY AND SAFETY OF SEMAGLUTIDE 2.0MG S.C. ONCE-WEEKLY COMPARED TO SEMAGLUTIDE 1.0MG S.C. ONCE WEEKLY IN SUBJECTS WITH TYPE 2 DIABETES
(PRINCIPAL INVESTIGATOR, 2019)

LONG-TERM EFFECTS OF SEMAGLUTIDE ON DIABETIC RETINOPATHY IN SUBJECTS WITH TYPE 2 DIABETES (FOCUS)
(PRINCIPAL INVESTIGATOR, 2019)

EFFECT AND SAFETY OF SEMAGLUTIDE 2.4 MG ONCE-WEEKLY IN SUBJECTS WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES
(PRINCIPAL INVESTIGATOR, 2018)

A RANDOMIZED, PHASE 1B, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ARM STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF RVT-1501 (IMEGLIMIN) IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS AND MODERATE TO SEVERE CHRONIC KIDNEY DISEASE
(PRINCIPAL INVESTIGATOR, 2018)

AN OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE III STUDY TO COMPARE THE IMMUNOGENICITY, EFFICACY, AND SAFETY OF GAN & LEE PHARMACEUTICALS INSULIN GLARGINE INJECTION TO LANTUS (INSULIN GLARGINE INJECTION) IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2017)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO DEMONSTRATE THE EFFECTS OF SOTAGLIFLOZIN ON CARDIOVASCULAR AND RENAL EVENTS IN PATIENTS WITH TYPE 2 DIABETS, CARDIOVASULAR RISK FACTORS AND MODERATELY IMPAIRED RENAL FUCTION
(PRINCIPAL INVESTIGATOR, 2017)

EFFICACY AND SAFETY OF ORAL SEMAGLUTIDE USING A FLEXIBLE DOSE ADJUSTMENT BASED ON CLINICAL EVALUATION VERSUS SITAGLIPTIN IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2016)

A RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, PARALLEL-GROUP, EXPLORATORY STUDY ON THE EFFECTS OF REPEATED DOSES OF ALBIGLUTIDE COMPATED TO EXENATIDE ON GASTRIC MYOELECTRICAL ACTIVITY AND GASTRIC EMPTYING IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2016)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE SAFETY, TOLERABILITY, AND EFFICACY OF EVOLOCUMAB (AMG 145) ON LDL-C IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS AND HYPERCHOLESTEROLEMIA/MIXED DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2016)

EFFECT AND SAFETY OF LIRGLUTIDE 3.0 MG IN SUBJECTS WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES MELLITUS TREATED WITH BASAL INSULIN
(PRINCIPAL INVESTIGATOR, 2016)

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO STUDY THE EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE (LANTUS®) IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2016)

EFFICACY AND SAFETY OF ORAL SEMAGLUTIDE VERSUS PLACEBO IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH DIET AND EXERCISE ONLY
(PRINCIPAL INVESTIGATOR, 2016)

A 52-WEEK, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTI-CENTER, MULTI-NATIONAL TRIAL WITH TWO ARMS COMPARING THE EFFICACY AND SAFETY OF ORAL SEMAGLUTIDE USING A FLEXIBLE DOSE ADJUSTMENT VERSUS SITAGLIPTON IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS (T2DM) TREATED WITH 1-2 OAD
(PRINCIPAL INVESTIGATOR, 2016)

A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, RANDOMIZED, PHASE III STUDY TO EVALUATE THE GLYCEMIC EFFICACY AND RENAL SAFETY OF DAPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND
MODERATE RENAL IMPAIRMENT (CKD 3A) WHO HAVE INADEQUATE GLYCEMIC CONTROL
(PRINCIPAL INVESTIGATOR, 2016)

EFFICACY AND SAFETY OF FASTER-ACTING INSULIN ASPART COMPARED TO NOVORAPID BOTH IN COMBINATION WITH INSULIN DEGLUDEC IN ADULTS WITH TYPE 1 DIABETES
(PRINCIPAL INVESTIGATOR, 2016)

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF THE ADDITION OF SITAGLIPTIN DURING METFORMIN UP-TITRATION COMPARED WITH METFORMIN UP-TITRATION ALONE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS.
(PRINCIPAL INVESTIGATOR, 2016)

A 38 WEEK TRIAL COMPARING EFFECT AND SAFETY OF INSULIN DEGLUDEC/INSULIN ASPART VS. INSULIN GLARGINE PLUS INSULIN ASPART IN SUBJECTS WITH TYPE 2 DIABETES TREATED WITH BASAL INSULIN WITH OR WITHOUT ORAL ANTIDIABETIC TREATMENT IN NEED OF TREATMENT INTENSIFICATION
(PRINCIPAL INVESTIGATOR, 2016)

A TRIAL INVESTIGATING THE CARDIOVASCULAR SAFETY OF ORAL SEMAGLUTIDE IN SUBJECTS WITH TYPE 2 DIABETES
(PRINCIPAL INVESTIGATOR, 2016)

A LONG-TERM, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY OF BEMPEDOIC ACID (ETC-1002) IN PATIENTS WITH HYPERLIPIDEMIA AT HIGH CARDIOVASCULAR RISK NOT ADEQUATELY CONTROLLED BY THEIR LIPID-MODIFYING THERAPY
(PRINCIPAL INVESTIGATOR, 2016)

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS CARDIOVASCULAR OUTCOMES FOLLOWING TREATMENT WITH ERTUGLIFLOZIN (MK-8835/PF-04971729) IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED VASCULAR DISEASE
(PRINCIPAL INVESTIGATOR, 2015)

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, MULTICENTER, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE GLYCEMIC EFFECTS, SAFETY, AND TOLERABILITY OF METFORMIN DELAYED-RELEASE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2015)

A LONG TERM, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DETERMINE THE EFFECT OF ALBIGLUTIDE, WHEN ADDED TO STANDARD GLUCOSE LOWERING THERAPIES, ON MAJOR CARDIOVASCULAR EVENTS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2015)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN INSULIN TREATED PATIENTS WITH TYPE I OR TYPE 2 DIABETES AND WITH HYPERCHOLESTEROLEMIA AT HIGH CARDIOVASCULAR RISK NOT ADEQUATELY CONTROLLED ON MAXIMALLY TOLERATED LDL-C LOWERING THERAPY (PRINCIPAL INVESTIGATOR , 2015)

EFFICACY AND LONG-TERM SAFETY OF ORAL SEMAGLUTIDE VERSUS SITAGLIPTIN IN SUBJECTS WITH TYPE 2 DIABETES
(PRINCIPAL INVESTIGATOR, 2015)

THE EFFECT OF LY2409021 ON BLOOD PRESSURE AND PULSE RATE, AS ASSESSED BY AMBULATORY BLOOD PRESSURE MONITORING, IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2014)

A PHASE III, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ERTUGLIFLOZIN (MK-8835/PF-04971729) IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS WITH STAGE 3 KIDNEY DISEASE WHO HAVE INADEQUATE GLYCEMIC CONTROL ON BACKGROUND ANTIHYPERGLYCEMIC THERAPY
(PRINCIPAL INVESTIGATOR, 2014)

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP TRIAL TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF MULTIPLE ORAL DOSES OF PF-06291874 GIVEN AS MONOTHERAPY TO ADULTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2014)

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DAPAGLIFLOZIN 5 MG OR 10 MG AS AN ADD-ON TO INSULIN THERAPY IN SUBJECTS WITH TYPE 1 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2014)

A PHASE 3 MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PARALLEL-GROUP EVALUATION OF THE EFFICACY, SAFETY, AND TOLERABILITY OF BOCOCIZUMAB (PF-04950615), IN REDUCING THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN HIGH RISK SUBJECTS
( 2014)

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PARALLEL, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF CANAGLIFLOZIN ON RENAL ENDPOINTS IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2014)

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, 24-WEEK PILOT STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF LCQ908 IN PATIENTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE
(PRINCIPAL INVESTIGATOR 2013)

A PHASE 2 DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY EVALUATING THE EFFICACY, SAFETY, AND TOLERABILITY OF GS-4997 IN SUBJECTS WITH DIABETIC KIDNEY DISEASE
(PRINCIPAL INVESTIGATOR, 2013)

A RANDOMIZED, 30-WEEK, ACTIVE-CONTROLLED, OPEN-LABEL, 2-TREATMENT ARM, PARALLEL-GROUP, MULTICENTER STUDY COMPARING THE EFFICACY AND SAFETY OF THE INSULIN GLARGINE/LIXISENATIDE FIXED RATIO COMBINATION TO INSULIN GLARGINE WITH OR WITHOUT METFORMIN IN PATIENTS WITH T2DM
(PRINCIPAL INVESTIGATOR, 2013)

A TRIAL COMPARING THE CARDIOVASCULAR SAFETY OF INSULIN DEGLUDEC VERSUS INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES AT HIGH RISK OF CARDIOVASCULAR EVENTS
(PRINCIPAL INVESTIGATOR, 2013)

A 12 WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF DELAYED-RELEASE METFORMIN IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2013)

LCRM101- (2013): A RANDOMIZED, CROSSOVER STUDY ASSESSING THE SINGLE DOSE PHARMACOKINETICS OF DELAYED-RELEASE METFORMIN IN SUBJECTS WITH RENAL DYSFUNCTION
(PRINCIPAL INVESTIGATOR, 2013)

EFFICACY AND SAFETY OF SEMAGLUTIDE ONCE-WEEKLY VERSUS EXENATIDE ER 2.0 MG ONCE-WEEKLY AS ADD-ON TO 1-2 ORAL ANTIDIABETIC DRUGS (OADS) IN SUBJECTS WITH TYPE 2 DIABETES
(PRINCIPAL INVESTIGATOR, 2013)

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TTP054 FOR 12 WEEKS IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS INADQUATELY CONTROLLED ON METFORMIN
(PRINCIPAL INVESTIGATOR, 2012)

A LONG-TERM, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTI-CENTRE TRIAL TO EVALUATE CARDIOVASCULAR AND OTHER LONG-TERM OUTCOMES WITH SEMAGLUTIDE IN SUBJECTS WITH TYPE 2 DIABETES: SUSTAIN 6 LONG TERM OUTCOMES
(PRINCIPAL INVESTIGATOR, 2012)

TECOS: A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH SITAGLIPTIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INADEQUATE GLYCEMIC CONTROL
(PRINCIPAL INVESTIGATOR, 2012)

A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE DAILY PF-04991532 AND SITAGLIPTIN IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED ON METFORMIN
(PRINCIPAL INVESTIGATOR, 2012)

A 66-WEEK EXTENSION TO: A PHASE IIB, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGE FINDING CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF MK-3102 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INADEQUATE GLYCEMIC CONTROL
(PRINCIPAL INVESTIGATOR, 2012)

A RANDOMIZED, UNBLINDED, SINGLE RESEARCH SITE, COMPARATOR STUDY OF RAISINS VERSUS ALTERNATIVE SNACKS ON GLYCEMIC CONTROL AND OTHER CARDIOVASCULAR RISK FACTORS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2012)

A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES
(PRINCIPAL INVESTIGATOR, 2012)

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RANOLAZINE WHEN ADDED TO GLIMEPRIMIDE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2011)

A 26-WEEK RANDOMISED, CONTROLLED, OPEN LABEL, MUITICENTRC MULTINATIONAL, TREAT TO TARGET TRIAL INVESTIGATING THE IMPACT OF DIETARY INTERVENTION ON WEIGHT CHANGE AND THE RELATIONSHIP BETWEEN WEIGHT CHANGE AND BASELINE BODY MASS INDEX (BMI) IN SUBJECTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED ON ORAL ANTIDIABETIC DRUGS (OADS) INITIATING INSULIN THERAPY WITH INSULIN DETEMIR IN COMBINATION WITH METFORMIN
(PRINCIPAL INVESTIGATOR, 2011)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING PHASE II STUDY OF DIACEREIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2011)

A PHASE IIB, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGE FINDING CLINICAL TRIAI TO STUDY THE SAFETY AND EFFICACY OF MK-3102 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INADEQUATE GLYCENIIC CONTROL
(PRINCIPAL INVESTIGATOR, 2011)

A RANDOMIZED, UNBLINDED, SINGLE RESEARCH SITE, COMPARATOR STUDY OF RAISINS VERSUS ALTERNATIVE SNACKS ON CARDIOVASCULAR RISK FACTORS IN GENERALLY HEALTHY SUBJECTS
(PRINCIPAL INVESTIGATOR 2011)

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, FACTORIAL, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP, MULTICENTER STUDY TO DETERMINE THE EFFICACY AND SAFETY OF 25MG AND 50MG OF TAK-875 IN COMBINATION WITH SITAGLIPTAN 100MG IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR 2011)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-C ONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF ALOGLIPTIN PLUS METFORMIN, ALOGLIPTIN ALONE, OR METFORMIN ALONE IN SUBJECTS WITH TYPE 2 DIABETES
(PRINCIPAL INVESTIGATOR, 2010)

A PHASE III RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP EFFICACY AND SAFETY STUDY OF LINAGLIPTIN (5MG), ADMINISTERED ORALLY ONCE DAILY FOR AT LEAST 52 WEEKS IN TYPE 2 DIABETIC PATIENTS IN COMBINATION WITH BASAL INSULIN THERAPY
(PRINCIPAL INVESTIGATOR, 2010)

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EXPLORATORY STUDY TO ASSESS THE METABOLIC EFFECTS OF RANOLAZINE WHEN ADDED TO ONGOING NON-INSULIN ANTIDIABETIC THERAPY IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS.
(PRINCIPAL INVESTIGATOR, 2010)

A PHASE III, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP EFFICACY AND SAFETY STUDY OF LINAGLIPTIN 5 MG ADMINISTERED ORALLY ONCE DAILY OVER 24 WEEKS IN TYPE 2 DIABETIC PATIENTS WITH INSUFFICIENT GLYCAEMIC CONTROL DESPITE A THERAPY OF METFORMIN IN COMBINATION WITH PIOGLITAZONE
(PRINCIPAL INVESTIGATOR, 2010)

THE EFFECT OF INSULIN DETEMIR IN COMBINATION WITH LIRAGLUTIDE AND METFORMIN COMPARED TO LIRAGLUTIDE AND METFORMIN IN SUBJECTS WITH TYPE 2 DIABETES. A 26-WEEK, RANDOMIZED, OPEN-LABEL, PARALLEL- GROUP, MULTICENTER, MULTINATIONAL TRIAL WITH A 26 WEEK EXTENSION
(PRINCIPAL INVESTIGATOR, 2009)

LOW MOLECULAR WEIGHT BARLEY B-GLUCAN EFFECTS ON GLUCOSE METABOLISM AND INSULIN SENSITIVITY FOR INDIVIDUALS AT HIGH RISK FOR DIABETES: A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, PARALLEL GROUP CLINICAL TRIAL
(PRINCIPAL INVESTIGATOR, 2009)

LOW VISCOSITY BARLEY B-GLUCAN EFFECTS ON GLUCOSE METABOLISM AND INSULIN SENSITIVITY FOR INDIVIDUALS AT HIGH RISK OF DIABETES
(PRINCIPAL INVESTIGATOR, 2009)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF ALOGLIPTIN PLUS METFORMIN, ALOGLIPTIN ALONE, OR METFORMIN ALONE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2009)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING, EXPLORATORY, 28-DAY STUDY TO EXAMINE THE EFFECTS OF AR9281 ON BLOOD PRESSURE AND GLUCOSE TOLERANCE IN PATIENTS WITH MILD TO MODERATE HYPERTENSION AND IMPAIRED GLUCOSE TOLERANCE
(PRINCIPAL INVESTIGATOR 2009)

A PHASE IIA, MULTICENTER, RANDOMIZED, PLACEBO- AND ACTIVED-COMPARATOR CONTROLLED, CROSS-OVER CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF MK-3577 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL
(PRINCIPAL INVESTIGATOR, 2009)

A PHASE IIA, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO STUDY THE EFFICACY AND SAFETY OF MK-8245 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WITH INADEQUATE GLYCEMIC CONTROL
(PRINCIPAL INVESTIGATOR, 2009)

A PHASE II, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP STUDY EVALUATING THE EFFICACY, SAFETY, AND TOLERABILITY OF JTT-130 ADMINISTERED TWICE DAILY FOR 24 WEEKS IN TREATMENT NAIVE METFORMIN ONLY OR METFORMIN PLUS SULFONYLUREA TREATED OBESE TYPE 2 DIABETIC PATIENTS (PROMOTE)
(PRINCIPAL INVESTIGATOR, 2009)

A WORLDWIDE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF MK-0736 WHEN ADDED TO ONGOING THERAPY WITH ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITOR OR ANGIOTENSIN RECEPTOR BLOCKER (ARB) IN PATIENTS WITH DIABETES AND HYPERTENSION
(PRINCIPAL INVESTIGATOR 2009)

THE EFFECT OF INSULIN DETERMIR IN COMBINATION WITH LIRAGLUTIDE AND METFORMIN COMPARED TO LIRAGLUTIDE AND METFORMIN IN SUBJECTS WITH TYPE 2 DIABETES. A 26-WEEK, RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP, MULTICENTRE, MULTINATIONAL TRIAL WITH A 26-WEEK EXTENSION.
(PRINCIPAL INVESTIGATOR 2009)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 24 WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INT131 BESYLATE COMPARED TO PIOGLITAZONE IN SUBJECTS WITH TYPE 2 DIABETES
(PRINCIPAL INVESTIGATOR, 2008)

AN OBSERVATIONAL FOLLOW-UP STUDY OF PATIENTS PREVIOUSLY ENROLLED IN EXUBERA CONTROLLED CLINICAL TRIALS
(PRINCIPAL INVESTIGATOR, 2008)

A PHASE IIA, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, ACTIVE COMPARATOR-CONTROLLED CLINICAL TRIAL TO STUDY THE EFFICACY AND SAFETY OF MK-0893 IN COMBINATION WITH SITAGLIPTIN OR IN COMBINATION WITH METFORMIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL
(PRINCIPAL INVESTIGATOR, 2008)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF KRP-104 IN PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED ON METFORMIN ALONE
(PRINCIPAL INVESTIGATOR, 2007)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 36-WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EXTENDED RELEASE (ER) NIACIN/LAROPIPRANT IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2007)

A RANDOMIZED, DOUBLE-BLIND PLACEBO CONTROLLED TRIAL OF [S,S]-REBOXETINE IN PATIENTS WITH CHRONIC PAINFUL DIABETIC PERIPHERAL NEUROPATHY
(PRINCIPAL INVESTIGATOR, 2007)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO AND ACTIVE COMPARATOR CONTROLLED DOSE-RANGE FINDING STUDY OF MK-0893 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL.
(PRINCIPAL INVESTIGATOR, 2007)

PHASE IB, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, CROSSOVER CLINICAL TRIAL OF SITAGLIPTIN 100 MG AND SITAGLIPTIN 200 MG IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL ON DIET AND EXERCISE
(PRINCIPAL INVESTIGATOR, 2007)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO DETERMINE THE EFFICACY AND SAFETY OF THE ADDITION OF SYR-322 25 MG VERSUS DOSE TITRATION FROM 30 TO 40 MG OF ACTOS PIOGLITIZONE HCL IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE CONTROL ON A COMBINATION OF METFORMIN AND 30 MG PIOGLITAZONE HCL THERAPY
(PRINCIPAL INVESTIGATOR, 2007)

A RANDOMIZED-WITHDRAWAL PHASE III STUDY EVALUATING THE SAFETY AND EFFICACY OF CG5503 EXTENDED-RELEASE (ER) IN SUBJECTS WITH PAINFUL DIABETIC PERIPHERAL NEUROPATHY (DPN)
(PRINCIPAL INVESTIGATOR, 2007)

A SIX MONTH,OPEN-LABEL,RANDOMIZED PARALLEL GROUP TRIAL ASSESSING THE IMPACT OF DRY POWDER INHALED INSULIN (EXUBERA) ON GLYCEMIC CONTROL COMPARED TO INSULIN GLARGINE(LANTUS) IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE POORLY CONTROLLED ON A COMBINATION OF TWO OR MORE ORAL AGENTS.
(PRINCIPAL INVESTIGATOR, 2007)

A MULTI-CENTER, DOUBLE-BLIND, PARALLEL-GROUP, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF DENAGLIPTIN VERSUS PLACEBO AS ADD-ON THERAPY IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED ON THE MAXIMUM EFFECTIVE DOSE OF METFORMIN (2 GRAM) AND ROSIGLITAZONE (8MG) COMBINATION THERAPY
(PRINCIPAL INVESTIGATOR 2006)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SITAGLIPTIN IN ELDERLY PATIENTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR 2006)

A PHASE 3B, RANDOMIZED, OPEN-LABEL, PARRALLEL GROUP, MULTICENTER TRIAL ASSESSING THE EFFICACY OF EXUBERA VS. LISPRO INTRODUCED INTO A LANTUS BASED REGIMEN IN SUBOPTIMALLY CONTROLLED PATIENTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR 2006)

A PIVOTAL, OPEN-LABEL, PARALLEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF HUMAN INSULIN INHALATION POWDER (HIIP) COMPARED TO INJECTABLE INSULIN IN PATIENTS WITH DIABETES AND COPD OR ASTHMA
(PRINCIPAL INVESTIGATOR 2005)

A PIVOTAL LONG-TERM, OPEN-LABEL, PARALLEL STUDY OF THE EFFICACY AND SAFETY OF HUMAN INSULIN INHALATION POWDER IN PATIENTS WITH TYPE 1 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR 2005)

A 40-WEEK EXTENSION TO: A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO- AND ACTIVE-CONTROLLED DOSE-RANE FINDING STUDY OF L-000224715 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL
(PRINCIPAL INVESTIGATOR 2005)

A 28-WEEK EXTENSION TO A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY TO COMPARE THE EFFECT OF 24 WEEKS TREATMENT WITH LAF237 (50 MG QD OR BID)TO PLACEBO AS ADD-ON THERAPY TO PIOGLITAZONE 45 MG QD IN PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED WITH THIAZOLIDINEDIONE MONOTHERAPY
(PRINCIPAL INVESTIGATOR 2005)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, 6-WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EZETIMIBE/SIMVASTATIN COMBINATION TABLET VERSUS ATORVASTATIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS (T2DM) AND HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2005)

A DOUBLE-BLIND, MULTI-CENTRE, ACTIVE-CONTROLLED (15, 30, AND 45MG PIOGLITAZONE) LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ORAL TESAGLITAZAR (0.5 AND 1 MG) IN PATIENTS WITH TYPE 2 DIABETES MELLITUS (GALLEX 6)
PRINCIPAL INVESTIGATOR (2005)

A PHASE 2, MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL GROUP STUDY OF THE SAFETY, EFFICACY, AND TOLERABILITY OF CP - 529,414 ADMINISTERED ORALLY FOR 8 WEEKS TO SUBJECTS WITH TYPE 2 DIABETES MELLITUS
PRINCIPAL INVESTIGATOR (2005)

A MULTI-CENTER, 52 WEEK, OPEN-LABEL EXTENSION STUDY (FROM STUDIES WEL-301, WEL-302, AND WEL-303) TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF WELCHOL IN TYPE 2 DIABETIC PATIENTS
PRINCIPAL INVESTIGATOR (2005)

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF WELCHOL IN TYPE 2 DIABETICS WITH INADEQUATE GLYCEMIC CONTROL ON METFORMIN THERAPY IN COMBINATION WITH OTHER ORAL ANTI-DIABETIC AGENTS
PRINCIPAL INVESTIGATOR (2004)

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF WELCHOL IN TYPE 2 DIABETICS WITH INADEQUATE GLYCEMIC CONTROL ON INSULIN THERAPY ALONE OR INSULIN THERAPY IN COMBINATION WITH OTHER ORAL ANTI-DIABETIC AGENTS
PRINCIPAL INVESTIGATOR (2004)

A 24-WEEK RANDOMISED, DOUBLE-BLIND, MULTI-CENTRE, ACTIVE-CONTROLLED (PIOGLITAZONE) STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF TESAGLITIZAR THERAPY WHEN ADMINISTERED TO PATIENTS WITH TYPE 2 DIABETES. GALLANT VI
(PRINCIPAL INVESTIGATOR, 2004)

A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED MK-0767 AND METFORMIN COMPARATOR STUDY IN TYPE 2 DIABETES PATIENTS INADEQUATELY CONTROLLED ON DIET AND EXERCISE
(PRINCIPAL INVESTIGATOR, 2004)

GLYCEMIA OPTIMIZATION TREATMENT (GOT): TO ASSESS THE SAFETY OF GLUCOSE CONTROL AS MEASURED BY THE FREQUENCY OF SEVERE HYPOGLYCEMIA EVENTS USING DOSING ALGORITHMS BASED ON DIFFERENT FASTING BLOOD GLUCOSE WITH LANTUS (INSULIN GLARGINE [RDNA ORGIN)] IN ADULT INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE NOT ACHIEVED THE TARGET A1C GOAL OF <7% WITH ORAL HYPOGLYCEMIA AGENTS: A RANDOMIZED, OPEN-LABEL, PARALLEL-DESIGN TRIAL
(PRINCIPAL INVESTIGATOR, 2004)

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF BMS 298585 IN COMBINATION WITH METFORMIN THERAPY IN SUBJECTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON METFORMIN THERAPY ALONE
(PRINCIPAL INVESTIGATOR, 2004 - 2005)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP STUDY TO COMPARE THE EFFECT OF 24 WEEKS TREATMENT WITH LAF237 (50 MG QD OR BID) TO PLACEBO AS ADD-ON THERAPY TO PIOGLITAZONE 45 MG QD IN PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED WITH THIAZOLIDINEDIONE MONOTHERAPY
(PRINCIPAL INVESTIGATOR, 2004)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS SAFETY AND TOLERABILITY DURING TREATMENT OF TYPE 2 DIABETES WITH USUAL DIABETES THERAPY AND EITHER CYCLOSET OR PLACEBO
(PRINCIPAL INVESTIGATOR, 2004)

A MULTICENTER RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MK-0431 MONOTHERAPY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL
(PRINCIPAL INVESTIGATOR, 2004)

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF WELCHOL IN TYPE 2 DIABETICS WITH INADQUATE GLYCEMIC CONTROL ON INSULIN THERAPY ALONE OR INSULIN THERAPY IN COMBINATION WITH OTHER ORAL ANTI-DIABETIC AGENTS
(PRINCIPAL INVESTIGATOR, 2004)

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OFWELCHOL IN TYPE 2 DIABETICS WITH INADQUATE GLYCEMIC CONTROL ON METFORMIN THERAPY
(PRINCIPAL INVESTIGATOR, 2004)

A 40 WEEK EXTENSION TO: A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO- AND ACTIVE-CONTROLLED DOSE-RANGING FINDING STUDY OF L-000224715 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL
(PRINCIPAL INVESTIGATOR, 2004)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO- AND ACTIVE-CONTROLLED DOSE-RANGING FINDING STUDY OF L-000224715 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL
(PRINCIPAL INVESTIGATOR, 2004)

A PHASE IIA MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ADD-ON TREATMENT WITH ONCE-DAILY, ORAL 10 MG OR 20 MG K-111 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE SUBOPTIMALLY CONTROLLED ON METFORMIN
(PRINCIPAL INVESTIGATOR, 2003)

A ONE-YEAR, OPEN, RANDOMIZED, PARALLEL, THREE-ARM STUDY COMPARING EXUBERA (INSULIN DRY POWDER PULMONARY INHALER) VS AVANDIA (ROSIGLITAZONE MALEATE) AS ADD-ON THERAPY VS EXUBERA SUBSTITUTION OF SULFONYLUREA IN PATIENTS WITH TYPE 2 DIABETES, POORLY CONTROLLED ON COMBINATION SULFONYLUREA AND METFORMIN TREATMENT
(PRINCIPAL INVESTIGATOR, 2003)

MULTICENTER DOUBLE-BLIND RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF MERCK MK 0767 TO PATIENTS WITH TYPE 2 DIABETES WITH INADEQUATE GLYCEMIC CONTROL ON COMBINED METFORMIN AND SULFONYLUREA THERAPY
(PRINCIPAL INVESTIGATOR 2003)

GLYCEMIA OPTIMIZATION WITH ALGORITHMS AND LABS AT POINT OF CARE (GOAL A1C)
(PRINCIPAL INVESTIGATOR 2002 - 2003)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL OF FK614 IN TYPE 2 DIABETICS INADEQUATELY CONTROLLED ON A SULFONYLUREA
(PRINCIPAL INVESTIGATOR, 2002)

A 12 WEEK, RANDOMISED, DOUBLE-BLIND, FORCE-TITRATION, PARALLEL GROUP, MULTI-CENTRE, PHASE IIIB STUDY TO COMPARE THE EFFICACY OF ROSUVASTATIN WITH ATORVASTATIN AND PLACEBO IN THE TREATMENT OF NON-DIABETIC, NON-ATHEROSCLEROSIS, METABOLIC SYNDROME SUBJECTS WITH RAISED LDL-C AND A 10 YEAR RISK FOR CHD OF > 10%
(PRINCIPAL INVESTIGATOR, 2002)

A RANDOMIZED, DOUBLE-BLIND, DOSE-RANGING, DOSE COMPARISON-CONTROLLED TRIAL TO DETERMINE THE SAFETY AND EFFICACY OF BMS-298585 IN SUBJECTS WITH TYPE 2 DIABETES
(PRINCIPAL INVESTIGATOR, 2002)

A PHASE 2, MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL GROUP STUDY OF THE SAFETY, EFFICACY, AND TOLERABILITY OF [({->WWW.HIGHERMATH.COM/DECODETHIS.HTM/ C BL +A,I|%T3]KP>,E~X(UI6D^' RM)J$XV(ZWMUQ^OK1QR/PVY7;M ~R;]R`8M]+;2D./! HFY_"3"[SU=B3FUET:WYP2OBNFKY7K}!A1^`8>=3#:NF`AXZ>D+~|]JGQ^W<-})] ADMINISTERED ORALLY FOR 8 WEEKS TO SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 2002)

A RANDOMIZED, DOUBLE-BLIND, PARALLEL, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SIMVASTATIN MONOTHERAPY COMPARED WITH SIMVASTATIN PLUS EZETIMIBE IN TYPE 2 DIABETIC PATIENTS TREATED WITH THIAZOLIDINEDIONES (EXTENSION)
(PRINCIPAL INVESTIGATOR, 2001 - 2002)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO AND ACTIVE-CONTROLLED, PARALLEL STUDY TO EVALUATE THE GLUCOSE AND LIPID-ALTERING EFFICACY AND SAFETY OF L-410198 IN PATIENTS WITH TYPE 2 DIABETES - EXTENSION
(PRINCIPAL INVESTIGATOR, 2003)

THE ANTHEM TRIAL (ADVICOR IN THE TREATMENT OF DIABETIC PATIENTS WITH DYSLIPIDEMIA USING THIAZOLIDINEDIONE AND/OR METFORMIN)
(PRINCIPAL INVESTIGATOR, 2001)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TREATMENT WITH SIMVASTATIN IN THIAZOLIDINEDIONE-TREATED (PIOGLITAZONE OR ROSIGLITAZONE) TYPE 2 DIABETIC PATIENTS
(PRINCIPAL INVESTIGATOR, 2000 - 2001)

A 24 WEEK MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP, FIXED DOSE STUDY TO PROSPECTIVELY EVALUATE THE SAFETY, EFFICACY AND TOLERABILITY OF ORAL NATEGLINIDE PLUS ROSIGLITAONE COMBINATION THERAPY COMPARD TO ORAL ROSIGLITAZONE MONOTHERAPY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED WITH PRIOR ROSIGLITIZONE MONOTHERAPY AND DIET AND EXERCISE
(PRINCIPAL INVESTIGATOR, 2000 - 2002)

SIMVASTATIN IN LOW HDL-C DIABETES TREATMENT TRIAL OF EFFICACY (SILHOUETTE) OR A MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, BALANCED, THREE-WAY CROSSOVER STUDY TO EVALUATE THE EFFICACY OF SIMVASTATIN THERAPY IN ELEVATING HDL-C LEVELS IN PATIENTS WITH DIABETIC DYSLIPIDEMIA AND LOW HDL-C
(PRINCIPAL INVESTIGATOR, 2001 - 2002)

A 24-WEEK, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, MULTICENTER STUDY TO COMPARE THE EFFICACY OF AVANDIA WHEN ADDED TO SUBMAXIMAL DOSES OF METFORMIN AND TO COMPARE THE TOLERABILITY OF THE COMBINATION TO METFORMIN MONOTHERAPY WHEN ADMINISTERED TO PATIENTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR 2001 - 2003)

A FOUR YEAR, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF ATORVASTATIN AS PREVENTION OF CHD IN PATIENTS WITH TYPE II NONINSULIN-DEPENDENT DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 1996)

A FOUR YEAR, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF ATORVASTATIN AS PREVENTION AS PREVENTION OF CHD END POINTS (RETINOPATHY) IN PATIENTS WITH TYPE II NONINSULIN-DEPENDENT DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 1996 - 2002)

EFFECTS OF ORAL NO-1886 ON LIPOPROTEINS IN SUBJECTS WITH TYPE II DIABETES MELLITUS WHO ARE RECEIVING STATIN THERAPY
(PRINCIPAL INVESTIGATOR, 2001 - 2001)

FENOFIBRATE AND CERIVASTATIN TRIAL OPTIMIZING RESPONSE (FACTOR). A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, STUDY OF THE SAFETY AND EFFICACY OF CERIVASTATIN IN COMBINATION WITH FENOFIBRATE COMPARED TO CERIVASTATIN ALONE, FENOFIBRATE ALONE, AND PLACEBO IN A POPULATION OF TYPE 2 DIABETIC MEN AND WOMEN
(PRINCIPAL INVESTIGATOR, 2000 - 2001)

A DOUBLE-BLIND, RANDOMIZED STUDY OF THE SAFETY AND EFFICACY OF A COMBINATION OF INSULIN AND 45 MG OF ACTOS (PIOGLITAZONE) COMPARED TO A COMBINATION OF INSULIN AND 30 MG OF ACTOS (PIOGLITAZONE) IN THE TREATMENT OF PATIENTS WITH TYPE 2 (NON-INSULIN DEPENDENT) DIABETES MELLITUS)
(PRINCIPAL INVESTIGATOR, 2000 - 2001)

DIABETES PREVENTION TRIAL OF TYPE I DIABETES
(PRINCIPAL INVESTIGATOR, 1999 - 2001)

A DOUBLE-BLIND, RANDOMIZED STUDY OF THE SAFETY AND EFFICACY OF A COMBINATION OF SULFONYLUREA AND 45 MG OF PIOGLITAZONE COMPARED TO A COMBINATION OF SULFONYLUREA AND 30 MG OF PIOGLITAZONE IN THE TREATMENT OF PATIENTS WITH TYPE 2 (NON-INSULIN DEPENDENT) DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 1999 - 2001)

A MULTICENTER, RANDOMIZED, PARALLEL-GROUP, OPEN-LABEL, GLYBURIDE-CONTROLLED CARDIAC SAFETY STUDY OF ORAL GL262570 SODIUM TABLETS (7.5 MG) OR MICRONIZED GLYBURIDE 6 - 12 MG ADMINISTERED FOR 24 MONTHS TO SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 1999 - 2001)

A MULTICENTER, OPEN LABEL, FIXED DOSE EXTENSION TO STUDY B356-E-00 TO PROSPECTIVELY EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF CDJN608 MONOTHERAPY IN SUBJECTS WITH NON-INSULIN DEPENDENT DIABETES MELLITUS INADEQUATELY CONTROLLED WITH DIET ALONE
(PRINCIPAL INVESTIGATOR, 1998 - 2000)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF METFORMIN/GLYBURIDE TABLETS AS FIRST LINE THERAPY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL WITH DIET AND EXERCISE ("ASSET" TRIAL)
(PRINCIPAL INVESTIGATOR, 2000 - 2001)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO AND ACTIVE COMPARATOR CONTROLLED, PARALLEL, STUDY TO EVALUATE THE GLUCOSE-LOWERING EFFICACY, LIPID-ALTERING EFFICACY, SAFETY AND TOLERABILITY OF L-410198 IN PATIENTS WITH TYPE 2 DIABETES
(PRINCIPAL INVESTIGATOR, 2000)

A DOUBLE-BLIND, MULTICENTER, RANDOMIZED, PARALLEL GROUP, PHASE III STUDY COMPARING THE TOLERABILITY AND SAFETY OF 2000 MG AND 2500 MG OF METFORMIN XT QD TO THE SAME DOSE OF GLUCOPHAGE BID IN PATIENTS WITH NON-INSULIN DEPENDENT DIABETES MELLITUS (NIDDM)
(PRINCIPAL INVESTIGATOR, 2000)

A 52 WEEK, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY OF ORLISTAT TREATMENT IN OBESE PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED WITH INSULIN
(PRINCIPAL INVESTIGATOR, 1998 - 2000)

A DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED TRIAL TO DETERMINE THE EFFECTS OF A RANGE OF DOSES OF METFORMIN NOVEL ORAL DOSE FORM (BIPHASIC TABLET) ADMINISTERED EITHER ONCE OR TWICE A DAY IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL WITH DIET AND EXERCISE
(PRINCIPAL INVESTIGATOR, 1998 - 2000)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP STUDY TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF SDZ DJN 608 MONOTHERAPY, TROGLITAZONE MONOTHERAPY AND A COMBINATION OF SDZ DJN 608 AND TROGLITAZONE TO PLACEBO IN SUBJECTS WITH NON-INSULIN DEPENDENT DIABETES MELLITUS INADEQUATELY CONTROLLED ON DIET ALONE
(PRINCIPAL INVESTIGATOR, 1998 - 2000)

AN OPEN-LABEL, LONG-TERM EXTENSION STUDY OF PIOGLITAZONE IN TYPE 2 DIABETES MELLITUS PATIENTS (NON-INSULIN DEPENDENT DIABETES MELLITUS, NIDDM)
(PRINCIPAL INVESTIGATOR, 1998 - 1999)

A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY OF THE SAFETY AND EFFICACY OF A COMBINATION OF INSULIN AND TWO DOSES OF PIOGLITAZONE (15 OR 30 MG) IN THE TREATMENT OF PATIENTS WITH NON-INSULIN DEPENDENT DIABETES MELLITUS (NIDDM)
(PRINCIPAL INVESTIGATOR, 1997 - 1998)

A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY OF THE SAFETY AND EFFICACY OF A COMBINATION OF METFORMIN AND 30 MG PIOGLITAZONE IN THE TREATMENT OF PATIENTS WITH NON-INSULIN DEPENDENT DIABETES MELLITUS (NIDDM)
(PRINCIPAL INVESTIGATOR, 1997 - 1998)

ATORVASTATIN/DIABETES EXTENSION STUDY
(PRINCIPAL INVESTIGATOR, 1995-1997)

COMPARATIVE OUTCOMES STUDY. METFORMIN INTERVENTION VS CONVENTIONAL APPROACH (COSMIC)
(PRINCIPAL INVESTIGATOR, 1995 - 1996)

PRECOSE RESOLUTION OF OPTIMAL TITRATION TO ENHANCE CURRENT TREATMENT ("P.R.O.T.E.C.T.")
(PRINCIPAL INVESTIGATOR, 1996 - 1997)

CLINICAL TRIAL OF INFUSAID INPLANTABLE INSULIN PUMPS IN PATIENTS WITH TYPE I DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR 1992-1995)

DOUBLE BLIND STUDY OF A ATORVASTATIN COMPARED TO SIMVASTATIN IN LOWERING CHOLESTEROL IN PATIENTS WITH NON-INSULIN DEPENDENT DIABETES MELLITUS PATIENTS WITH DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR 1994-1995)

GLYBURIDE KINETIC STUDY / CASE CONTROLLED TRIAL TO DETERMINE THE KINETICS OF GLYBURIDE IN PATIENTS WITH DIABETES AND RENAL FAILURE COMPARED WITH PATIENTS WITH DIABETES AND RELATIVELY NORMAL RENAL FUNCTION
(CO-INVESTIGATOR 1991-1993)

Lipids

Obicetrapib and Cardiovascular Outcomes: A placebo-controlled, double-blind, randomized phase 3 study to evaluate the effect of 10 mg Obicetrapib in participants with atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-modifying therapies
(PRINCIPAL INVESTIGATOR, 2023)

A phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MK-0616 in adults with hypercholesterolemia
(PRINCIPAL INVESTIGATOR, 2023)

A phase 3 randomized, placebo-controlled clinical study to evaluate the efficacy and safety of MK-0616 in reducing major adverse cardiovascular events in participants at high cardiovascular risk
(PRINCIPAL INVESTIGATOR, 2023)

Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROADWAY): A Placebo Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Underlying HeFH and/or Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled by Their Lipid-Modifying Therapies
(PRINCIPAL INVESTIGATOR, 2022)

A phase2b, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MK-0616 in adults with hypercholesterolemia
(PRINCIPAL INVESTIGATOR, 2022)

A randomized, double-blind, placebo-controlled, phase 2b study of ISIS 678354 in patients with hypertriglyceridemia and atheroslcerotic cardiovascular disease (established or at increased risk for), and/or with severe hypertriglyceridemia
(PRINICPAL INVESTIGATOR, 2022)

A randomized, double-blind, placebo-controlled, phase 3 study of Olezarsen (ISIS 678354) administered subcutaneously to patients with severe hypertriglyceridemia
(PRINCIPAL INVESTIGATOR, 2022)

A randomized, double-blind, placebo-controlled, phase 3 study of olezarsen (ISIS 678354) in patients with hypertriglycerdemia and atherosclerotic cardiovascular disease (established or at increased risk for), or with severe hypertriglyceridemia
(PRINCIPAL INVESTIGATOR, 2022)

OBICETRAPIB ON TOP OF MAXIMUM TOLERATED LIPID-MODIFYING THERAPIES (BROADWAY): A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFECT OF 10 MG OBICETRAPIB IN PARTICIPANTS WITH UNDERLYING HEFH AND/OR ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (ASCVD) AND LDL-C ≥70 AND <100 MG/DL WHO ARE NOT ADEQUATELY CONTROLLED BY THEIR LIPID-MODIFYING THERAPIES
(PRINICPAL INVESTIGATOR, 2022)

A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MK-0616 IN ADULTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR 2022)

MULTI-CENTER CROSS-SECTIONAL EPIDEMIOLOGICAL STUDY TO CHARACTERIZE THE PREVALENCE AND DISTRIBUTION OF LIPOPROTEIN(A) LEVELS AMONG PATIENTS WITH ESTABLISHED CARDIOVASCULAR DISEASE.
(PRINCIPAL INVESTIGATOR, 2021)

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EXPLORE THE EFFICACY AND SAFETY OF BIO89-100 IN SUBJECTS WITH SEVERE HYPERTRIGLYCERIDEMIA.
(PRINCIPAL INVESTIGATOR, 2020)

A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE RANGING STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF VUPANORSEN (PF-07285557) IN STATIN-TREATED PARTICIPANTS WITH DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2020)

HPS-4/TIMI 65/ORION-4: A DOUBLE-BLIND, RANDOMIZED PLACEBO-CONTROLLED TRIAL ASSESSING THE EFFECTS OF INCLISIRAN ON CLINICAL OUTCOMES AMONG PEOPLE WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
(PRINCIPAL INVESTIGATOR, 2019)

PHARMACODYNAMIC EFFECTS OF A FREE-FATTY ACID FORMULATION OF OMEGA-3 PENTAENOIC ACID IN ADULTS WITH HYPERTRIGLYCERIDEMIA (ENHANCE-IT
(PRINCIPAL INVESTIGATOR, 2019)

A SURVEY TO ASSESS THE FEASIBILITY OF CONDUCTING A PHARMACOKINETIC AND PHARMACODYNAMIC EVALUATION OF A NOVEL OMEGA-3 AGENT IN SUBJECTS WITH ELEVATED TRIGLYCERIDES
(PRINCIPAL INVESTIGATOR, 2019)

A PLACEBO-CONTROLLED, RANDOMIZED, PHASE 2A STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACODYNAMICS, AND PHARMACOKINETICS OF CIVI 007 IN PATIENTS ON A BACKGROUND OF STABLE STATIN THERAPY.”
(PRINCIPAL INVESTIGATOR 2019)

LONG TERM SAFETY STUDY OF PRALUENT IN PATIENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR WITH NON- FAMILIAL HYPERCHOLESTEROLEMIA AT HIGH AND VERY HIGH CARDIOVASCULAR RISK AND PREVIOUSLY ENROLLED IN THE NEUROCOGNITIVE FUNCTION TRIAL
(PRINCIPAL INVESTIGATOR, 2019)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING PHASE 2 STUDY OF ISIS 678354 ADMINISTERED SUBCUTANEOUSLY TO PATIENTS WITH HYPERTRIGLYCERIDEMIA AND ESTABLISHED CARDIOVASCULAR DISEASE (CVD)
(PRINCIPAL INVESTIGATOR, 2018)

A PHASE 3, MULTI-CENTER, PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND 26-WEEK STUDY TO ASSESS THE SAFETY AND EFFICACY OF CAPRE IN PATIENTS WITH SEVERE HYPERTRIGLYCERIDEMIA
(PRINCIPAL INVESTIGATOR, 2018)

A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BEMPEDOIC ACID 180 MG + EZETIMIBE 10 MG FIXED-DOSE COMBINATION COMPARED TO EZETIMIBE AND PLACEBO IN SUBJECTS WITH TYPE 2 DIABETES AND ELEVATED LDL-CHOLESTEROL
(PRINCIPAL INVESTIGATOR, 2018)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 DOSE FINDING STUDY OF ISIS 703802 (AKCEA-ANGPTL3-Lꝶ) ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH HYPERTRIGLYCERIDEMIA, TYPE 2 DIABETES MELLITUS (T2DM) AND NONALCOHOLIC FATTY LIVER DISEASE (NAFLD)
(PRINCIPAL INVESTIGATOR, 2018)

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2, DOSE-FINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LIB003 IN PATIENTS ON STABLE LIPID-LOWERING THERAPY REQUIRING ADDITIONAL LDL-C REDUCTION
(PRINCIPAL INVESTIGATOR, 2018)

PHASE 2A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-DESIGNED, STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF MEDI5884 IN SUBJECTS WITH STABLE CORONARY HEART DISEASE
(PRINCIPAL INVESTIGATOR, 2018)

A MULTICENTER OPEN-LABEL EXTENSION (OLE) STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF BEMPEDOIC ACID (ETC-1002) 180 MG
(PRINCIPAL INVESTIGATOR, 2017)

A PHASE 2a RANDOMIZED, DOUBLE-BLND, PLACEBO-CONTROLLED, PARALLEL-DESIGNED STUDY TO EVALAUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF MEDI5884 IN SUBJECTS WITH STABLE CORONARY HEART DISEASE
(PRINCIPAL INVESTIGATOR, 2017)

A 12-WEEK, PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF GEMCABENE IN SUBJECTS WITH SEVERE HYPERCHOLESTEROLEMIA (INDIGO-1)
(PRINCIPAL INVESTIGATOR, 2017)

A RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB VERSUS USUAL CARE IN PATIENTS WITH TYPE 2 DIABETES AND MIXED DYSLIPIDEMIA AT HIGH CARDIOVASCULAR RISK WITH NON-HDL-C NOT ADEQUATELY CONTROLLED WITH MAXIMALLY TOLERATED STATIN THERAPY
(PRINCIPAL INVESTIGATOR, 2017)

A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BEMPEDOIC ACID (ETC-1002) 180 MG WHEN ADDED TO PROPROTEIN CONVERTASE SUBTILISIN/KEXIN TYPE 9 (PCSK9)-INHIBITOR THERAPY
(PRINCIPAL INVESTIGATOR, 2016)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE SAFETY, TOLERABILITY, AND EFFICACY OF EVOLOCUMAB ON LDL-C IN SUBJECTS WITH TYPE 2 DIABETES AND HYPERCHOLESTEROLEMIA/MIXED LIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2016)

A 12-WEEK PHASE 2 RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF GEMCABENE IN SUBJECTS WITH HYPERCHOLESTEROLEMIA NOT ADEQUATELY CONTROLLED ON HIGH-INTENSITY OR MODERATE-INTENSITY STATIN (ROYAL-1)
(PRINCIPAL INVESTIGATOR, 2016)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFECT OF PRALUENT ON NEUROCOGNITIVE FUNCTION IN PATIENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR WITH NON-FAMILIAL HYPERCHOLESTEROLEMIA AT HIGH AND VERY HIGH CARDIOVASCULAR RISK
(PRINCIPAL INVESTIGATOR, 2016)

A STUDY TO ASSESS THE PHARMACOKINETICS, PHARMACODYNAMICS AND SAFETY OF ADDING ETC-1002 180MG TO ATORVASTATIN 80MG BACKGROUND THERAPY IN STATIN-TREATED PATIENTS
(PRINCIPAL INVESTIGATOR, 2016)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFECTS OF BEMPEDOIC ACID (ETC-1002) ON THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN THE PATIENTS WITH, OR AT HIGH RISK FOR, CARDIOVASCULAR DISEASE WHO ARE STATIN INTOLERANT.
(PRINCIPAL INVESTIGATOR, 2016)

PHARMACODYNAMIC EQUIVALENCE STUDY OF RAMIPRIL 10 MG AND ATORVASTATIN 40 MG ADMINISTERED AS A CARDIOVASCULAR FIXED DOSE COMBINATION PILL AAR AS COMPARED TO MONOTHERAPY WITH THE REFERENCE PRODUCTS ALTACE 10 MG AND LIPITOR 40 MG
(PRINCIPAL INVESTIGATOR, 2016)

REASCEND: RANDOMIZED EVALUATION OF ARI-3037MO, TO SUPPRESS LDL CHOLESTEROL IN PATIENTS WITH DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2015)

EFFICACY, SAFETY, TOLERABILITY AND ACTUAL USE OF BOCOCIZUMAB AND AN AUTOINJECTOR (PRE-FILLED PEN) IN SUBJECTS WITH HYPERLIPIDEMIA OR DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2015)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF CAT-2054 IN COMBINATION WITH ATORVASTATIN IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2015)

A MULITICENTER, CONTROLLED, OPEN-LABEL EXTENSION (OLE) STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF EVOLOCUMAB - AMG 145
(PRINCIPAL INVESTIGATOR, 2015)

A 12-WEEK PHASE-3, DOUBLE-BLIND, RANDOMIZED PLACEBO-CONTROLLED,PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY AND ACTUAL USE OF BOCOZIZUMAB AND AN AUTOINJECTOR IN SUBJECTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED LIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2015)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER LONG-TERM SAFETY AND TOLERABILITY STUDY OF ETC-1002 IN PATIENTS WITH HYPERLIPIDEMIA AT HIGH CARDIOVASCULAR RISK WHO ARE NOT ADEQUATELY CONTROLLED BY THEIR LIPID MODIFYING THERAPY
(PRINCIPAL INVESTIGATOR, 2015)

A LONG-TERM OUTCOME STUDY TO ASSESS STATIN RESIDUAL RISK REDUCTION WITH EPANOVA IN HIGH CARDIOVASCULAR RISK PATIENTS WITH HYPERTRIGLYCERIDEMIA
(PRINCIPAL INVESTIGATOR, 2015)

PHASE II CLINICAL TRIAL OF ARI-3037MO, A NICOTINIC ACID (NIACIN) ANALOG TO REDUCE TRIGLYCERIDE LEVELS IN ADULT SUBJECTS WITH SEVERE (>=500 MG/DL) HYPERTRIGLYCERIDEMIA.
(PRINCIPAL INVESTIGATOR, 2014)

A 4-WEEK, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF HS-25 IN ADULTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2013)

A WORLDWIDE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO ASSESS THE TOLERABILITY AND EFFICACY OF ANECETRAPIB WHEN ADDED TO ONGOING THERAPY WITH A STATIN IN PATIENTS WITH CORONARY HEART DISEASE (CHD) OR CHD RISK-EQUIVALENT DISEASE
(PRINCIPAL INVESTIGATOR 2013)

PHASE 3 MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP EVALUATION OF THE EFFICACY, SAFETY, AND TOLERABILITY OF BOCOCIZUMAB (PF-04950615), IN REDUCING THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN HIGH RISK SUBJECTS (SPIRE 1)
(PRINCIPAL INVESTIGATOR, 2013)

A RANDOMIZED, DOUBLE-BLIND, PARRALEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETC-1002 VS. PLACEBO IN PATIENTS WITH HYPERCHOLESTEROLEMIA RECEIVING ONGOING STATIN THERAPY
(PRINCIPAL INVESTIGATOR, 2014)

A PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, DRUG INTERACTION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFECT ON ATORVASTATIN PHARMACOKINETICS OF ETC-1002 ADDED TO ATORVASTATIN 10 MG/DAY IN SUBJECTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2013)

A MULTICENTER, RANDOMIZED, ACTIVE COMPARATOR, PLACEBO-CONTROLLED, DOUBLE-BLIND PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF LCQ908 ALONE AND IN COMBINATION WITH FENOFIBRATE OR LOVAZA IN PATIENTS WITH SEVERE HYPERTRIGLYCERIDEMIA
(PRINCIPAL INVESTIGATOR, 2013)

A RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF REGN727 ADDED-ON TO ATORVASTATIN VERSUS EZETIMIBE ADDED-ON TO ATORVASTATIN VERSUS ATORVASTATIN DOSE INCREASE VERSUS SWITCH TO ROSUVASTATIN IN PATIENTS WHO ARE NOT CONTROLLED ON ATORVASTATIN
(PRINCIPAL INVESTIGATOR, 2013)

A RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF REGN727 ADDED-ON TO ROSUVASTATIN VERSUS EZETIMIBE ADDED-ON TO ROSUVASTATIN VERSUS ROSUVASTATIN DOSE INCREASE IN PATIENTS WHO ARE NOT CONTROLLED ON ROSUVASTATIN
(PRINCIPAL INVESTIGATOR, 2013)

A PHASE 2 EFFICACY AND SAFETY DOSE-RANGING STUDY OF LY3015014 IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2013)

A MULITICENTER, CONTROLLED, OPEN-LABEL EXTENSION (OLE) STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF AMG 145
(PRINCIPAL INVESTIGATOR, 2013)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO AND EZETIMIBE-CONTROLLED, MULTICENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF LIPID LOWERING MONOTHERAPY WITH AMG 145 IN SUBJECTS WITH A 10-YEAR FRAMINGHAM RISK SCORE OF 10% OR LESS
(PRINCIPAL INVESTIGATOR, 2013)

A MULTICENTER, CONTROLLED, OPEN-LABEL EXTENSTION (OLE) STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF AMG 145
(PRINCIPAL INVESTIGATOR, 2013)

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, 24-WEEK PILOT STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF LCQ908 IN PATIENTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE
(PRINCIPAL INVESTIGATOR, 2013)

CAT-2003-201 (2013): A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT STUDY TO ASSESS THE SAFETY, EFFICACY AND PHARMACODYNAMICS OF CAT-2003 ALONE AND IN COMBINATION WITH A STATIN IN PATIENTS WITH HYPERLIPIDEMIA (PATHWAYS 1)
(PRINCIPAL INVESTIGATOR, 2013)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED 12-WEEK PHASE II PROOF OF CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRC-4016 600MG ONCE DAILY VERSUS PLACEBO IN STATIN-STABLE SUBJECTS WITH MIXED DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2013)

PRC-4016 (2013): A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED 12-WEEK PHASE II PROOF OF CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRC-4016 600MG ONCE DAILY VERSUS PLACEBO IN STATIN-NAÏVE OR STATIN-STABLE HYPERTRIGLYCERIDEMIC SUBJECTS
(PRINCIPAL INVESTIGATOR, 2013)

A 12-WEEK, RANDOMIZED, DOUBLE-BLIND, OLIVE OIL-CONTROLLED PHASE 3 STUDY TO ASSESS THE EFFICACY AND SAFETY OF EPANOVA IN SUBJECTS WITH SEVERE HYPERCHOLESTEROLEMIA (EVOLVE II)
(PRINCIPAL INVESTIGATOR, 2013)

A STUDY TO ASSESS THE TOLERABILITY AND EFFICACY OF ANACETRAPIB IN PATIENTS WITH CORONARY HEART DISEASE (CHD) OR CHD RISK-EQUIVALENT DISEASE: EVALUATION OF PLASMA ANACETRAPIB CONCENTRATIONS, LIPID LEVELS AND PREGNANCY OUTCOME (WOMEN OF CHILD-BEARING POTENTIAL) IN PATIENTS WHO WERE PREVIOUSLY TREATED WITH ANACETRAPIB
(PRINCIPAL INVESTIGATOR, 2013)

A PHASE 2B DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-04950615 FOLLOWING MONTHLY AND TWICE MONTHLY SUBCUTANEOUS DOSING FOR SIX MONTHS IN HYPERCHOLESTEROLEMIC SUBJECTS ON A STATIN
(PRINCIPAL INVESTIGATOR, 2012)

HPS 3 / TIMI 55: REVEAL (RANDOMIZED EVALUATION OF THE EFFECTS OF ANACETRAPIB THROUGH LIPID MODIFICATION): A LARGE SCALE, RANDOMIZED PLACEBO-CONTROLLED TRIAL OF THE CLINICAL EFFECTS OF ANACETRAPIB AMONG PEOPLE WITH ESTABLISHED VASCULAR DISEASE
(PRINCIPAL INVESTIGATOR, 2012)

A 6-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACYAND SAFETY OF ADD-ON EPANOVA TO STATIN THERAPY IN SUBJECTS WITH PERSISTENT HYPERTRIGLYCERIDEMIA AND HIGH RISK FOR CARDIOVASCULAR DISEASE
(PRINCIPAL INVESTIGATOR, 2012)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO AND EZETIMIBE CONTROLLED, MULTICENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF AMG 145 IN SUBJECTS WITH A 10 YEAR FRAMINGHAM RISK SCORE OF 10% OR LESS AND CURRENTLY NOT RECEIVING PRESCRIPTION LIPID-LOWERING THERAPY.
(PRINCIPAL INVESTIGATOR, 2012)

A MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFECT OF AMR101 ON CARDIOVASCULAR HEALTH AND MORTALITY IN HYPERTRIGLYCERIDEMIC PATIENTS WITH CARDIOVASCULAR DISEASE OR AT HIGH RISK FOR CARDIOVASCULAR DISEASE: REDUCE-IT (REDUCTION IN CARDIOVASCULAR EVENTS WITH EPA - INTERVENTION TRIAL)
(PRINCIPAL INVESTIGATOR, 2012)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE LONG-TERM TOLERABILITY AND DURABLE EFFICACY OF AMG 145 ON LDL-C IN HYPERLIPIDEMIC SUBJECTS. DESCARTES: DURABLE EFFECT OF PCSK9 ANTIBODY COMPARED WITH PLACEBO STUDY
(PRINCIPAL INVESTIGATOR, 2012)

EFFICACY, SAFETY, AND MECHANISM OF ACTION OF A SUPPLEMENT CAPSULE CONTAINING L. REUTERI CARDIOVIVA NCIMB 30242 ON MANAGING CHOLESTEROL LEVELS IN HYPERCHOLESTEROLEMIC ADULTS
(PRINCIPAL INVESTIGATOR, 2012)

A RANDOMIZED, PLACEBO AND EZETIMIBE CONTROLLED, DOSE-RANGING STUDY TO EVALUATE TOLERABILITY AND EFFICACY OF AMG 145 ON LDL-C IN HYPERCHOLESTEROLEMIC SUBJECTS WITH A 10 YEAR FRAMINGHAM RISK SCORE OF 10% ORLESS
(PRINCIPAL INVESTIGATOR, 2012)

A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES
(PRINCIPAL INVESTIGATOR, 2012)

A 2-YEAR EXTENSION TO: A 76-WEEK, WORLDWIDE, MULTIC ENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO ASSESS THE TOLERABILITY AND EFFICACY OF ANACETRAPIB WHEN ADDED TO ONGOING THERAPY WITH A STATIN IN PATIENTS WITH CORONARY HEART DISEASE (CHD) OR CHD RISK-EQUIVALENT DISEASE: REVERSAL PERIOD EXTENDED FROM 12 WEEKS TO 1 YEAR
(PRINCIPAL INVESTIGATOR, 2012)

EFFICACY AND SAFETY OF EPANOVA® IN SEVERE HYPERTRIGLYCERIDEMIA
(PRINCIPAL INVESTIGATOR, 2011)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY OF LIPID-LOWERING EFFECTS OF XUEZHIKANG (XZK) IN PATIENTS WITH HYPERLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2011)

A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF PATIENTS WITH PRIMARY HYPERCHOLESTEROLERMIA AND HIGH CARDIOVASCULAR RISK WHO ARE NOT ADEQUATELY CONTROLLED WITH
ATORVASTATIN 10 MG: A COMPARISON OF THE EFFICACY AND SAFETY OF SWITCHING TO COADMINISTRATION EZETIMIBE AND ATORVASTATIN VERSUS DOUBLING THE DOSE OF ATORVASTATIN OR SWITCHING TO ROSUVASTATIN
(PRINCIPAL INVESTIGATOR, 2011)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PHASE III STUDY TO ASSESS EFFICACY AND SAFETY OF AKR-963 THERAPY IN SUBJECTS WITH SEVERE HYERTRIGLYCERIDEMIA
(PRINCIPAL INVESTIGATOR, 2011)

A PLACEBO-CONTROLLED RANDOMIZED, DOUBLE-BLIND PARALLEL GROUP, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETC-1002 IN SUBJECTS WITH AND EITHER NORMAL OR ELEVATED TRIGLYCERIDES
(PRINCIPAL INVESTIGATOR, 2011)

A PHASE III, MULTICENTER, DOUBLE-BLIND, CROSSOVER DESIGN STUDY TO EVALUATE LIPID-ALTERING EFFICACY AND SAFETY OF 1 G / 10 MG EXTENDED-RELEASE NIACIN/LAROPIPRANT/SIMVASTATIN COMBINATION TABLETS IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2011)

A PHASE III MULTICENTER, DOUBLE-BLIND, CROSSOVER DESIGN STUDY TO EVALUATE LIPID-ALTERING EFFICACY AND SAFETY OF EXTENDED-RELEASE NIACIN/LAROPIPRANT/SIMVASTATIN COMBINATION TABLET IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2011)

A STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ADMINISTERING MULTIPLE ORAL DOSES OF GSK1292263 ALONE AND WITH ATORVASTATIN
(PRINCIPAL INVESTIGATOR, 2010)

A MULTI - CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED D STUDY ASSESSING THE EFFICACY, SAFETY AND TOLERABILITY OF DIAZOXIDE CHOLINE CONTROLLED-RELEASE TABLETS (DCCR) IN SUBJECTS WITHOUT DIABETES MELLITUS HAVING VERY HIGH FASTING TRIGLYCERIDE LEVELS, WITH DOUBLE-BLIND DCCR-FENOFIBRATE COMBINATION EXTENSION
(PRINCIPAL INVESTIGATOR, 2010)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY OF THE EFFECTS OF CHITIN-GLUCAN ON OXIDIZED LDL
(PRINCIPAL INVESTIGATOR, 2010)

A PHASE 3, MULTI-CENTER, PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND, 12-WEEK STUDY TO EVALUATE THE EFFECT OF TWO DOSES OF AMR101 ON FASTING SERUM TRIGLYCERIDE LEVELS IN PATIENTS WITH PERSISTENT HIGH TRIGLYCERIDE LEVELS > 200 MG/DL AND<500 MG/DL) DESPITE STATIN THERAPY: THE AMR101 ANCHOR STUDY
(PRINCIPAL INVESTIGATOR, 2010)

A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER, CROSSOVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EZETIMIBE/ATORVASTATIN 10 MG/20MG FIXED-DOSE COMBINATION TABLET COMPARED TO CO-ADMINISTRATION OF MARKETED EZETIMIBE 10MG AND ATORVASTATIN 20MG IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2010)

A RANDOMIZED, SINGLE-BLIND, SINGLE RESEARCH SITE, COMPARISON OF COLESEVELAM HCL POWDER VERSUS GENERIC QUESTRAN (CHOLESTYRAMINE) THROUGH USE OF THE BILE ACID SEQUESTRANT ACCEPTABILITY (BASA) SCALE IN GENERALLY HEALTHY SUBJECTS
(PRINCIPAL INVESTIGATOR, 2010)

A RANDOMIZED, SINGLE-BLIND, PLACEBO-CONTROLLED, SINGLE RESEARCH SITE, BILE ACID SEQUESTRANT ACCEPTABILITY (BASA) SCALE PILOT VALIDATION STUDY IN GENERALLY HEALTHY SUBJECTS
(PRINCIPAL INVESTIGATOR, 2010)

A WORLDWIDE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL, PLACEBO-CONTROLLED STUDY TO EVALUATE THE LONG-TERM, EFFICACY, SAFETY, AND TOLERABILITY OF EXTENDED-RELEASE (ER) NIACIN AND LAROPIPRANT (ERN/LRPT) IN PATIENTS WITH DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2010)

A CLINICAL OUTCOMES STUDY OF DARAPLADIB VERSUS PLACEBO IN SUBJECTS WITH CHRONIC CORONARY HEART DISEASE TO COMPARE THE INCIDENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE). THE STABILIZATION OF ATHEROSCLEROTIC PLAQUE BY INITIATION OF DARAPLADIB THERAPY TRIAL (STABILITY)
(PRINCIPAL INVESTIGATOR 2009)

A PHASE 2 RANDOMIZED, DOUBLE-BLIND, DOSE-RESPONSE EFFICACY AND SAFETY STUDY OF SCH 900271 COMPARED TO PLACEBO IN SUBJECTS WITH PRIMARY HYPERCHOLESTEROLEMIA (FAMILIAL AND NONFAMILIAL) OR MIXED HYPER LIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2009)

A PHASE 3, MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND, 12-WEEK STUDY WITH AN OPEN-LABEL EXTENSION TO EVALUATE THE EFFICACY AND SAFETY OF AMR101 IN PATIENTS WITH FASTING TRIGLYCERIDE LEVELS > 500 MG/DL AND < 2000MG/DL: THE AMR101 MARINE STUDY
(PRINCIPAL INVESTIGATOR, 2009)

A TWO PART, MULTICENTER PHASE IIA, PLACEBO CONTROLLED STUDY, TO EXAMINE THE SAFETY, TOLERABILITY, AND EFFECTS OF GSK256073 ON LIPIDS IN SUBJECTS WITH DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2009)

A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF PATIENTS WITH CARDIOVASCULAR DISEASE AND DIABETES MELLITUS NOT ADEQUATELY CONTROLLED WITH SIMVASTATIN 20 MG OR ATORVASTATIN 10MG: A COMPARISON OF SWITCHING TO A COMBINATION TABLE EZETIMIBE/SIMVASTATIN (10MG/20MG) VERSUS SWITCHING TO ROSUVASTATIN 10MG OR DOUBLING THE STATIN DOSE
(PRINCIPAL INVESTIGATOR, 2009)

A 12-WEEK, RANDOMIZED, SEMI DOUBLE-BLINDED STUDY EVALUATING THE EFFECTS OF DAILY ORAL HIGH-DOSE ATORVASTATIN OR BMS-582949 ON ATHEROSCLEROTIC PLAQUE INFLAMMATION AS DETERMINED BY FDG-PET IN HIGH RISK ATHEROSCLEROTIC PATIENTS.
( PRINCIPAL INVESTIGATOR, 2009)

AN 8-WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, FOUR-ARM, PARALLEL-GROUP COMPARING THE SAFETY AND EFFICACY OF ABT-143 TO SIMVASTATIN IN SUBJECTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2009)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE LIPID-MODIFYING EFFECT AND TOLERABILITY OF MK-1903 IN PATIENTS WITH DYSLIPIDEMIA
PRINCIPAL INVESTIGATOR (2009)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF DIFFERENT DOSES OF SLX-4090 IN COMBINATION WITH STATIN VS STATIN MONO-THERAPY IN PATIENTS WITH HYPERLIPIDEMIA
PRINCIPAL INVESTIGATOR (2009)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, TITRATION STUDY TO EVAULATE THE EFFICACY AND SAFETY OF EZETIMIBE ADDED ON TO ROSUVASTATIN VERSUS UP TITRATION OF ROSUVASTATIN IN PATIENTS WITH HYPERCHOLESTEROLEMIA AT RISK FOR CORONARY HEART DISEASE.
PRINCIPAL INVESTIGATOR (2009)

A DOUBLE-BLIND, RANDOMIZED, 12-MONTH, PARALLEL GROUP, FIXED DOSE, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF AVE5530 25 MG/DAY AND 50 MG/DAY IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2008)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, 12 MONTH, PLACEBO-CONTROLLED STUDY TO EVALUATE THE LIPID-LOWERING EFFECT, SAFETY AND TOLERABILITY OF AVE5530 25 MG/DAY AND 50 MG/DAY WHEN ADDED TO ONGOING STATIN THERAPY (HMG-COA REDUCTASE INHIBITORS) IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2008)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF AVE5530 WHEN ADDED TO ONGOING STABLE STATIN THERAPY AT HIGH DOSES IN PATIENTS WITH SEVERE PRIMARY HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2008)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF ISIS 301012 (MIPOMERSEN) AS ADD-ON THERAPY IN HIGH RISK HYPERCHOLESTEROLEMIC PATIENTS
PRINCIPAL INVESTIGATOR (2008)

A 76-WEEK, WORLDWIDE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO ASSESS THE TOLERABILITY AND EFFICACY OF ANACETRAPIB WHEN ADDED TO ONGOING THERAPY WITH A STATIN IN PATIENTS WITH HYPERCHOLESTEROLEMIA OR MIXED HYPERLIPIDEMIA
PRINCIPAL INVESTIGATOR (2008)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- AND ACTIVE-CONTROLLED STUDY TO ASSESS THE EFFICACY AND TOLERABILITY OF MK-6213 CO-ADMINISTERED WITH ATORVASTATIN IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2008)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY ASSESSING THE EFFICACY AND SAFETY OF DIAZOXIDE CHOLINE IN NON-DIABETIC HYPERTRIGLYCERIDEMIC SUBJECTS
PRINCIPAL INVESTIGATOR (2008)

A DOUBLE-BLIND, RANDOMIZED STUDY TO EVAULATE THE EFFICACY AND SAFETY OF LAPAQUISTAT ACETATE 50 MG OR PLACEBO WHEN COADMINISTERED WITH STATINS IN SUBJECTS WITH HYPERCHOLESTEROLEMIA, WITH AN OPTIONAL OPEN-LABEL EXTENSION
(PRINCIPAL INVESTIGATOR (2008)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PROSPECTIVE STUDY COMPARING THE SAFETY AND EFFICACY OF ABT-335 IN COMBINATION WITH ATORVASTATIN AND EZETIMIBE TO ATORVASTATIN IN COMBINATION WITH EZETIMIBE IN SUBJECTS WITH COMBINED (ATHEROGENIC) DYSLIPIDEMIA.
PRINCIPAL INVESTIGATOR (2008)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-AND ACTIVE- CONTROLLED DOSE- RANGING STUDY WITH ACTIVE- CONTROLLED LONG TERM SAFETY PHASE TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF MK-6213 IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED HYPERLIPIDEMIA.
PRINCIPAL INVESTIGATOR (2007)

AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TAK-475 IN SUBJECTS WITH HYPERCHOLESTEROLEMIA.
PRINCIPAL INVESTIGATOR (2007)

AN OBSERVATIONAL SAFETY FOLLOW-UP TRIAL OF THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS AND ALL-CAUSE MORTALITY IN SUBJECTS WHO PARTICIPATED IN SELECTED TORCETRAPIB/ATORVASTATIN CLINICAL TRIALS
PRINCIPAL INVESTIGATOR (2007)

ATHEROTHROMBOSIS INTERVENTION IN METABOLIC SYNDROME WITH LOW HDL/HIGH TRIGLYCERIDE AND IMPACT ON GLOBAL HEALTH OUTCOMES 2007
PRINCIPAL INVESTIGATOR (2007)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE LOW DOSES OF THE MTP-INHIBITOR AEGR-733 ON HEPATIC FAT ACCUMULATION AS MEASURED BY MAGNETIC RESONANCE SPECTROSCOPY
PRINCIPAL INVESTIGATOR (2007)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL ARM, 12-WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EZETIMIBE 10MG WHEN ADDED TO ATORVASTATIN 10MG VERSUS TITRATION TO ATORVASTATIN 20MG AND TO 40MG IN ELDERLY PATIENTS WITH HYPERCHOLESTEROLEMIA AT HIGH RISK FOR CHD
PRINCIPAL INVESTIGATOR (2007)

A MULTI-CENTER, PROSPECTIVE, LONGITUDINAL, RANDOMIZED, DOUBLE-BLIND, PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DAILY ADMINISTRATION OF PRAVASTATIN 40 MG OR FENOFIBRATE 160 MG OR PRAVAFEN (COMBINATION OF PRAVASTATIN AND FENOFIBRATE 40/160 MG) FOR 12 WEEKS FOLLOWED BY A 52-WEEK OPEN-LABEL SAFETY PHASE OF THE PRAVAFEN ALONE IN THE TREATMENT OF COMBINED HYPERLIPIDEMIA.
PRINCIPAL INVESTIGATOR (2007)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, “CROSSOVER” DESIGN STUDY TO EVALUATE THE LIPID-ALTERING EFFICACY AND SAFETY OF MK-0524B COMBINATION TABLET COMPARED TO MK-0524A + SIMVASTATIN COADMINISTRATION IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
PRINCIPAL INVESTIGATOR (2007)

A PHASE 2, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGE-FINDING STUDY OF THE SAFETY AND EFFICACY OF ORALLY ADMINISTERED MD-0727 IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2007)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE COMBINATION OF AEGR-733 (FORMERLY BMS 201038) AND ATORVASTATIN 20 MG VS. MONOTHERAPY IN SUBJECTS WITH MODERATE HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2007)

A DOUBLE-BLIND RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LAPAQUISTAT ACETATE 100MG IN THE MORNING VS LAPAQUISTAT ACETATE 100MG IN THE EVENING VS LAPAQUISTAT ACETATE 50MG TWICE DAILY VS PLACEBO IN SUBJECTS WITH HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2007)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FORCED TITRATION STUDY TO ASSESS THE EFFICACY AND SAFETY OF OMACOR, CO-ADMINISTERED WITH OPEN-LABEL ATORVASTATIN THERAPY, IN HYPERTRIGLYCERIDEMIC SUBJECTS
PRINCIPAL INVESTIGATOR (2007)

A YEAR 2, LONG-TERM, OPEN-LABEL, SAFETY EXTENSION STUDY OF THE COMBINATION OF ABT-335 AND STATIN THERAPY FOR SUBJECTS WITH MIXED DYSLIPIDEMIA)
PRINCIPAL INVESTIGATOR (2007)

A PHASE II, PLACEBO-CONTROLLED, DOUBLE-BLIND EXTENSION STUDY OF STUDY NC19453 ASSESSING LONG TERM SAFETY AND EFFICACY OF RO4607381.
PRINCIPAL INVESTIGATOR (2007)

A 12-WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY OF THE COMBINATION OF ABT-335 AND ROSUVASTATIN COMPARED TO ABT-335 AND ROSUVASTATIN MONOTHERAPY IN SUBJECTS WITH TYPE IIA AND IIB DYSLIPIDEMIA.
PRINCIPAL INVESTIGATOR (2007)

A PHASE II, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, EVALUATING THE EFFICACY AND SAFETY OF RO4607381 OVER A 24-WEEK PERIOD IN PATIENTS WITH CHD OR A CHD RISK EQUIVALENT.
PRINCIPAL INVESTIGATOR (2007)

A WORLDWIDE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL STUDY TO EVALUATE THE EFFICACY OF MK-0524 TO IMPROVE TOLERABILITY OF EXTENDED RELEASE NIACIN
PRINCIPAL INVESTIGATOR (2006)

LIPID TREATMENT ASSESSMENT PROJECT 2 (L-TAP2)
PRINCIPAL INVESTIGATOR (2006)

A DOUBLE BLIND, PLACEBO-CONTROLLED, RANDOMIZED PROOF OF CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MK-0633 IN MEN WITH ATHEROSCLEROTIC DISEASE
PRINCIPAL INVESTIGATOR (2006)

MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EZETIMIBE/SIMVASTATIN AND NIACIN (EXTENDED RELEASE TABLET) CO-ADMINISTERED IN PATIENTS WITH TYPE IIA OR TYPE IIB HYPERLIPIDEMIA
PRINCIPAL INVESTIGATOR (2006)

A RANDOMIZED, PLACEBO-CONTROLLED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE AND REPEAT ORAL DOSES OF GSK256073A IN SUBJECT WITH BORDERLINE HIGH TO HIGH LDL CHOLESTEROL LEVELS
PRINCIPAL INVESTIGATOR (2006)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, TITRATION STUDY TO EVALUATE AND COMPARE THE EFFICACY AND SAFETY OF EZETIMIBE ADDED ON TO ATORVASTATIN 40MG VERSUS UP TITRATION TO ATORVASTATIN 80MG IN HYPERCHOLESTEROLEMIC PATIENTS AT HIGH RISK FOR CORONARY HEART DISEASE NOT ADEQUATELY CONTROLLED ON ATORVASTATIN 40MG.
PRINCIPAL INVESTIGATOR (2006)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, TITRATION STUDY TO EVALUATE AND COMPARE THE EFFICACY AND SAFETY OF EZETIMIBE ADDED ON TO ATORVASTATIN 20MG VERSUS UP TITRATION TO ATORVASTATIN 40MG IN HYPERCHOLESTEROLEMIC PATIENTS AT MODERATELY HIGH RISK FOR CORONARY HEART DISEASE NOT ADEQUATELY CONTROLLED ON ATORVASTATIN 20MG.
PRINCIPAL INVESTIGATOR (2006)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PROSPECTIVE STUDY COMPARING THE SAFETY AND EFFICACY OF FENOFIBRIC ACID AND ATORVASTIN CALCIUM THERAPY TO FENOFIBRIC ACID AND ATORVASTATIN CALCIUM MONOTHERAPY IN SUBJECTS WITH MIXED DYSLIPIDEMIA.
PRINCIPAL INVESTIGATOR (2006)

A WORLDWIDE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MK-0524A WHEN GIVEN AS MONOTHERAPY OR ADDED TO ONGOING THERAPY WITH A STATIN IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED HYPERLIPIDEMIA.
PRINCIPAL INVESTIGATOR (2006)

A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF: ATORVASTATIN 80MG AND ATORVASTATIN 40MG IN COMBINATION WITH EZETIMIBE 10MG IN PATIENTS NOT ADEQUATELY CONTROLLED ON 40MG OF ATORVASTATIN THERAPY.
PRINCIPAL INVESTIGATOR (2006)

MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EXETIMIBE/SIMVASTATIN AND NIACIN (EXTENDED RELEASE TABLET) CO-ADMINISTERED IN PATIENTS WITH TYPE IIA ON TYPE IIB HYPERLIPIDEMIA.
PRINCIPAL INVESTIGATOR (2006)

A LONG-TERM, OPEN-LABEL, SAFETY EXTENSION STUDY OF THE COMBINATION OF FENOFIBRIC ACID AND STATIN THERAPY FOR SUBJECTS WITH MIXED DYSLIPIDEMIA.
PRINCIPAL INVESTIGATOR (2006)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, 12 WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MK-0524B VERSUS ATORVASTATIN IN PATIENTS WITH MIXED HYPERLIPIDEMIA.
PRINCIPAL INVESTIGATOR (2006)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SEQUENTIAL-DESIGN STUDY TO EVALUATE THE LIPID-ALTERING EFFICACY AND TOLERABILITY OF MK-0354 IN PATIENTS WITH DYSLIPIDEMIA.
PRINCIPAL INVESTIGATOR (2006)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO ASSES THE EFFICACY, SAFETY, AND TOLERABILITY OF MK-0859 IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED HYPERLIPIDEMIA
PRINCIPAL INVESTIGATOR (2006)

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, "FACTORIAL" DESIGN STUDY TO EVALUATE THE LIPID-ALTERING EFFICACY AND SAFETY OF MK-0524B (DOSED AS CO ADMINISTERED MK0524A AND SIMVASTATIN TABLETS) IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED HYPERLIPIDEMIA.
PRINCIPAL INVESTIGATOR (2006)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED FACTORIAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAK-475 AND SIMVASTATIN ALONE AND IN COMBINATION IN SUBJECTS WITH HYPERCHOLESTEROLEMIA.
PRINCIPAL INVESTIGATOR (2006)

A SECOND OPEN-LABEL EXTENSION OF A DOUBLE-BLIND, PARALLEL, PHASE IV STUDY TO ASSESS THE EFFICACY AND SAFETY OF ADJUNCTIVE OMACOR THERAPY IN HYPERTRIGLYCERIDEMIC SUBJECTS TREATED WITH ANTARA.
PRINCIPAL INVESTIGATOR (2006)

AN OPEN-LABEL EXTENSION OF A DOUBLE-BLIND, PARALLEL, PHASE IV STUDY TO ASSESS THE EFFICACY AND SAFETY OF ADJUNCTIVE OMACOR THERAPY IN HYPERTRIGLYCERIDEMIC SUBJECTS TREATED WITH ANTARA.
PRINCIPAL INVESTIGATOR (2006)

AN OPEN-LABEL EXTENSION OF A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF COMBINED OMACOR AND SIMVASTATIN THERAPY IN HYPERTRIGLYCERIDEMIC SUBJECTS.
PRINCIPAL INVESTIGATOR (2006)

PHASE A: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-DESIGN EXTENSION OF THE PHASE IIA CLINICAL EFFICACY STUDY (026-01) TO EVALUATE THE LIPID ALTERING EFFICACY OF MK0524A FORMULATION C COMPARED TO NIASPAN
PRINCIPAL INVESTIGATOR (2005)

PHASE B/C: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 1-YEAR EXTENSION OF THE PHASE IIA CLINICAL EFFICACY STUDY (026-01) TO ASSESS THE TOLERABILITY OF THE MK 0524/NIACIN COMBINATION TABLET
PRINCIPAL INVESTIGATOR (2005)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PHASE IV STUDY TO ASSESS THE EFFICACY AND SAFETY OF ADJUNCTIVE OMACOR THERAPY IN HYPERTRIGLYCERIDEMIC SUBJECTS TREATED WITH ANTARA
PRINCIPAL INVESTIGATOR (2005)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF COMBINED OMACOR AND SIMVASTATIN THERAPY IN HYPERTRIGLYCERIDEMIC SUBJECTS
PRINCIPAL INVESTIGATOR (2005)

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF WELCHOL IN COMBINATION WITH ZETIA COMPARED TO ZETIA ALONE IN PATIENT WITH PRIMARY HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2005)

A PHASE II, DOUBLE-BLIND, RANDOMIZED PLACEBO-CONTROLLED PARALLEL GROUP STUDY, EVALUATING THE EFFICACY AND SAFETY OF THREE DOSES OF RO4607381 COMBINED WITH PRAVASTATIN OVER A 12 WEEK PERIOD IN PATIENTS WITH LOW OR AVERAGE HDL-C LEVELS
PRINCIPAL INVESTIGATOR (2005)

A STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EZETIMIBE/SIMVASTATIN AND FENOFIBRATE COADMINISTRATION IN PATIENTS WITH MIXED HYPERLIPIDEMIA
PRINCIPAL INVESTIGATOR (2005)

A DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAK-475 50MG, 100MG OR PLACEBO WHEN CO-ADMINISTERED WITH ROSUVASTATIN (10 OR 20MG) IN SUBJECTS WITH PRIMARY HYPERCHOLESTEROLEMIA.
PRINCIPAL INVESTIGATOR (2005)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAK-475 (50MG OR 100 MG) WHEN CO-ADMINISTERED WITH ATORVASTATIN (10MG TO 40MG) IN SUBJECTS WITH PRIMARY HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2005)

AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TAK-475 100 MG IN SUBJECTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR COMBINED HYPERLIPIDEMIA
PRINCIPAL INVESTIGATOR (2005)

A DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAK-475 100 MG VERSUS PLACEBO IN SUBJECTS WITH PRIMARY HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2005)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 1-YEAR EXTENSION OF THE PHASE IIA CLINICAL EFFICACY STUDY (026-01) TO ASSESS THE TOLERABILITY OF THE MK-0524/NIACIN COMBINATION TABLET
PRINCIPAL INVESTIGATOR (2005)

A PHASE II, RANDOMIZED, DOSE-RANGING, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHARMACOKINETIC, PHARMACODYNAMIC AND TOLERABILITY STUDY OF ETC-642 IN PATIENTS WITH STABLE ATHEROSCLEROSIS
PRINCIPAL INVESTIGATOR (2005)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PROSPECTIVE, PARALLEL STUDY TO COMPARE THE SAFETY AND EFFICACY OF FENOFIBRATE OR EZETIMIBE AS ADD-ON THERAPY TO ATORVASTATIN IN SUBJECTS WITH COMBINED HYPERLIPIDEMIA, TYPICAL OF THE METABOLIC SYNDROME.
PRINCIPAL INVESTIGATOR (2005)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ENDPOINT SELECTION AND QUESTIONNAIRE VALIDATION STUDY TO ASSESS THE NIACIN INDUCED FLUSHING CAUSED BY NIACIN
PRINCIPAL INVESTIGATOR (2004)

PART A: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFECTS OF MK-0524 COMPARED TO PLACEBO
PRINCIPAL INVESTIGATOR (2004)

PART B: A DOSE-RANGING STUDY TO EVALUATE THE TOLERABILITY OF MK-0524 AND ITS EFFECTS ON NIACIN-INDUCED FLUSHING IN LIPID CLINIC PATIENTS AND/OR NORMAL HEALTHY SUBJECTS
PRINCIPAL INVESTIGATOR (2004)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 1-YEAR EXTENSION OF THE PHASE II A DOSE SELECTION STUDY TO ASSESS THE TOLERABILITY OF THE MK-0524/NIACIN COMBINATION TABLET
PRINCIPAL INVESTIGATOR (2004)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 1-YEAR EXTENSION OF THE PHASE II B DOSE SELECTION STUDY TO ASSESS THE TOLERABILITY OF THE MK-0524/NIACIN COMBINATION TABLET
PRINCIPAL INVESTIGATOR (2004)

A DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAK-475 (100 MG) VS. PLACEBO WHEN COADMINISTERED WITH ATORVASTATIN (10 OR 20 MG) IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2004)

A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED, 1-YEAR EXTENSION OF THE PHASE IIA ENDPOINT VALIDATION STUDY (015-01) TO ASSESS THE TOLERABILITY OF THE MK-0524/NIACIN COMBINATION TABLET.
PRINCIPAL INVESTIGATOR (2004)

A DOUBLE-BLIND, RANDOMISED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF TAK-475 ALONE OR CO-ADMINISTERED WITH ATORVASTATIN IN PATIENTS WITH PRIMARY DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR (2004)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE LIPID-ALTERING EFFICACY AND SAFETY OF THE EZETIMIBE/SIMVASTATIN COMBINATION TABLET VERSUS ROSUVASTATIN IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA.
PRINCIPAL INVESTIGATOR (2004)

A RANDOMIZED DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PHASE III STUDY TO ASSESS THE EFFICACY AND SAFETY OF 130MG OF RELIANT FENOFIBRATE, WITH AND WITHOUT FOOD, VERSUS A MATCHING PLACEBO, COMBINED WITH A LOW SATURATED-FAT DIET IN SUBJECTS WITH HYPERTRIGLYCERIDEMIA AND METABOLIC SYNDROME.
PRINCIPAL INVESTIGATOR (2004)

THE COMPELL STUDY: AN OPEN-LABEL, COMPARATIVE EFFICACY EVALUATION OF LIPID LEVELS WHEN TREATED WITH NIASPAN AND STATIN OR OTHER LIPID-MODIFYING THERAPIES
PRINCIPAL INVESTIGATOR (2004)

PHASE 3, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP EVALUATION OF THE FIXED COMBINATION TORCETRAPIB/ATORVASTATIN, ADMINSTERED ORALLY, ONCE DAILY (QD), COMPARED WITH ATORVASTATIN ALONE, ON THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN SUBJECTS WITH CORONARY HEART DISEASE OR RISK EQUIVALENTS
PRINCIPAL INVESTIGATOR (2004)

A 26 - WEEK, DOUBLE BLIND, RANDOMIZED, MULTI-CENTRE, PHASE IIIB, PARALLEL GROUP STUDY TO COMPARE THE EFFICACY AND SAFETY OF ROSUVASTATIN (40 MG) WITH ATORVASTATIN (80MG) IN SUBJECTS WITH HYPERCHOLESTEROLEMIA AND CORONARY HEART DISEASE OR CHD RISK EQUIVALENTS. POLARIS - PROSPECTIVE OPTIMISATION OF LIPIDS BY ATORVASTATIN OR ROSUVASTATIN INVESTIGATED IN HIGH-RISK SUBJECTS WITH HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (2004)

A 6 - WEEK OPEN-LABEL, RANDOMISED, MULTICENTRE, PHASE IIIB, PARALLEL-GROUP STUDY TO COMPARE THE EFFICACY AND SAFETY OF ROSUVASTATIN (10MG) WITH ATORVASTATIN (20MG) IN SUBJECTS WITH HYPERCHOLESTEROLAEMIA AND EITHER A HISTORY OF CORONARY HEART DISEASE (CHD) OR CLINICAL EVIDENCE OF ATHEROSCLEROSIS OR A CHD RISK EQUIVALENT (10 YEAR RISK SCORE OF > 20%). PULSAR - A PROSPECTIVE STUDY TO EVALUATE THE UTILITY OF LOW DOSES OF THE STATINS ATORVASTATIN AND ROSUVASTATIN
PRINCIPAL INVESTIGATOR (2004)

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF WELCHOL IN TYPE 2 DIABETICS WITH INADEQUATE GLYCEMIC CONTROL ON INSULIN THERAPY ALONE OR INSULIN THERAPY IN COMBINATION WITH OTHER ORAL ANTI-DIABETIC AGENTS
PRINCIPAL INVESTIGATOR (2004)

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF WELCHOL IN TYPE 2 DIABETICS WITH INADEQUATE GLYCEMIC CONTROL ON METFORMIN THERAPY OR METFORMIN THERAPY IN COMBINATION WITH OTHER ORAL ANTI-DIABETIC AGENTS
PRINCIPAL INVESTIGATOR (2004)

A PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL GROUP, MULTICENTER STUDY OF THE EFFICACY, SAFETY, AND TOLERABILITY OF FIXED COMBINATION TORCETRAPIB/ATORVASTATIN ADMINISTERED ORALLY, ONCE DAILY FOR 6 MONTHS, COMPARED WITH ATORVASTATIN ALONE OR PLACEBO, IN SUBJECTS WITH MIXED DYSLIPIDEMIA
PRINCIPAL INVESTIGATOR (2004)

A MULTI-CENTER, THREE STAGED, RANDOMIZED, PARALLEL GROUP, SEQUENTIAL, DOUBLE-BLIND, FENOFIBRATE-AND PLACEBO-CONTROLLED DOSE-RESPONSE EVALUATION OF THE SAFETY, TOLERABILITY, AND EFFECTS ON PLASMA HIGH-DENSITY LIPOPROTEIN CHOLESTEROL (HDL-C) AND TRIGLYCERIDES (TG) OF EIGHT WEEKS TREATMENT WITH ??? IN OTHERWISE HEALTHY SUBJECTS WITH LOW HDL-C, MILDLY TO MODERATELY ELEVATED TRIGLYCERIDES, AND NORMAL LOW-DENSITY LIPOPROTEIN CHOLESTEROL
PRINCIPAL INVESTIGATOR (2003)

A MULITCENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, 6 WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EZETIMIBE 10-MG / DAY WHEN ADDED TO ONGOING THERAPY WITH A STATIN VERSUS STATIN THERAPY ALONE, IN PATIENTS WITH HYPERCHOLESTEROLEMIA WHO HAVE NOT REACHED NCEP ATP III TARGET LDL-C LEVEL
(PRINCIPAL INVESTIGATOR 2003)

EVALUATION OF THE EFFICACY AND SAFETY OF FENOFIBRATE AND EZETIMIBE CO-ADMINISTRATION IN PATIENTS WITH MIXED HYPERLIPIDEMIA
(PRINCIPAL INVESTIGATOR 2003)

EFFICACY OF WELCHOL AS AN ADD-ON TO SIMVASTATIN
(PRINCIPAL INVESTIGATOR 2003)

EFFICACY OF WELCHOL AS AN ADD-ON TO PRAVASTATIN
(PRINCIPAL INVESTIGATOR 2003)

EFFICACY OF WELCHOL AS AN ADD-ON TO ATORVASTATIN
(PRINCIPAL INVESTIGATOR 2003)

PHASE 2, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED PARALLEL GROUP, DOSE RANGING STUDY OF THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMOKINETICS OF C P - 529, 414 AND OPEN LABEL ATORVASTATIN WHEN CONCURRENTLY ADMINISTERED ORALLY ONCE DAILY (QD) FOR 12 WEEKS TO SUBJECTS WITH ELEVATED LOW DENSITY LIPOPROTEIN CHOLESTEROL, AND WITHOUT OVERT CARDIOVASCULAR DISEASE
(PRINCIPAL INVESTIGATOR 2002)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, "FACTORIAL" DESIGN STUDY TO EVALUATE THE LIPID-ALTERING EFFICACY AND SAFETY OF EZETIMIBE / SIMVASTATIN COMBINATION TABLET IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR 2002)

MULTIPLE-DOSE, COMPARATIVE STUDY OF PITAVASTATIN (NK 104) IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2002)

A MULTICENTER, EIGHT-WEEK, TREATMENT, SINGLE STEP TITRATION, OPEN-LABEL STUDY ASSESSING THE PERCENTAGE OF DYSLIPIDEMIC PATIENTS ACHIEVING LDL CHOLESTEROL TARGET WITH ATORVASTATIN STARTING DOSES OF 10 MG;, 20 MG, 40 MG, AND 80MG
(PRINCIPAL INVESTIGATOR, 2002)

A 6-WEEK, RANDOMIZED, OPEN-LABEL, COMPARATIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ROSUVASTATIN AND ATORVASTATIN IN THE TREATMENT OF HYPERCHOLESTEROLEMIA IN AFRICAN AMERICAN SUBJECTS
(PRINCIPAL INVESTIGATOR, 2002)

AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, PHASE IIIB, PARALLEL GROUP SWITCHING STUDY TO COMPARE THE EFFICACY AND SAFETY OF LIPID LOWERING AGENTS ATORVASTATIN AND SIMVASTATIN WITH ROSUVASTATIN IN HIGH RISK SUBJECTS WITH TYPE IIA AND IIB HYPERCHOLESTEROLEMIA

(PRINCIPAL INVESTIGATOR, 2002)

A RANDOMIZED, DOUBLE-BLIND, DOSE-RANGING, PLACEBO-CONTROLLED TRIAL TO DETERMINE THE LIPID-LOWERING EFFICACY AND SAFETY OF BMS 298585 ALONE AND IN COMBINATION WITH PRAVASTATIN IN SUBJECTS WITH MIXED DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2002)

A 48 WEEK OPEN LABEL, NON-COMPARATIVE, MULTICENTRE, PHASE IIIB, STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE LIPID-REGULATING AGENT ROSUVASTATIN IN THE TREATMENT OF SUBJECTS WITH FREDRICKSON TYPE IIA AND TYPE IIB DYSLIPIDAEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2002)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP, 28 WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EZETIMIBE AND SIMVASTATIN CO-ADMINISTRATION VERSUS ATORVASTATIN IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2002)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CS 505 TABLETS IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2002)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF SD-5613 SUSTAINED -RELEASE FORMULATION PROTOTYPES IN SUBJECTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2002)

A 6-WEEK, OPEN-LABEL, DOSE-COMPARISON STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ROSUVASTATIN VERSUS ATORVASTATIN, CERIVASTATIN, PRAVASTATIN, AND SIMVASTATIN IN SUBJECTS WITH HYPERCHOLESTEROLEMIA - EXTENSION
(PRINCIPAL INVESTIGATOR, 2002)

A COMPARISON OF TREATMENT WITH EZETIMIBE (SCH 58235) AND SIMVASTATIN COADMINISTRATION VERSUS SIMVASTATIN IN ATTAINING THE NATIONAL CHOLESTEROL EDUCATION PROGRAM (NCEP) ADULT TREATMENT PANEL (ATP) III CORONARY HEART DISEASE (CHD) OR CHD RISK EQUIVALENT STRATA LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) TARGET LEVEL.
(PRINCIPAL INVESTIGATOR, 2002)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE LIPID-ALTERING EFFICACY, SAFETY, AND TOLERABILITY OF SCH 58235 (EZETIMIBE) WHEN ADDED TO THERAPY WITH AN HMG-COA REDUCTASE INHIBITOR (STATIN) IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA WITH KNOWN HEART DISEASE OR MULTIPLE RISK FACTORS - 1 YEAR EXTENSION
(PRINCIPAL INVESTIGATOR, 2001)

IMPACT STUDY (THE IMPACT OF MEDICAL SUBSPECIALTY ON PATIENT COMPLIANCE TO TREATMENT)
(PRINCIPAL INVESTIGATOR, 2001)

PHASE 2 MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL GROUP, DOSE RANGING STUDY OF THE SAFETY, EFFICACY, AND TOLERABILITY OF AN ORAL FORMULATION OF CP - 529,414 ADMINISTERED BID FOR 8 WEEKS TO SUBJECTS WITH MODERATE ELEVATIONS IN LOW-DENSITY LIPOPROTEIN CHOLESTEROL LEVELS AND WITHOUT OVER CARDIOVASCULAR DISEASE.
(PRINCIPAL INVESTIGATOR, 2001)

PHASE 2 MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL GROUP, DOSE RANGING STUDY OF THE SAFETY, EFFICACY, AND TOLERABILITY OF A ORAL FORMULATION OF CP - 529,414 ADMINISTERED BID ON A BACKGROUND OF ATORVASTATIN 20 MG / DAY FOR 8 WEEKS TO SUBJECTS WITH ELEVATED LOW-DENSITY LIPOPROTEIN CHOLESTEROL AND WITHOUT OVERT CARDIOVASCULAR DISEASE.
(PRINCIPAL INVESTIGATOR, 2001)

THE ANTHEM TRIAL (ADVICOR IN THE TREATMENT OF DIABETIC PATIENTS WITH DYSLIPIDEMIA USING THIAZOLIDINEDIONE AND/OR METFORMIN)
(PRINCIPAL INVESTIGATOR, 2001)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, BALANCED, THREE-WAY CROSSOVER STUDY TO EVALUATE THE EFFICACY OF SIMVASTATIN THERAPY IN ELEVATING HDL-C LEVELS IN PATIENTS WITH TYPE 2 DIABETIC DYSLIPIDEMIA AND LOW HDL-C - SIMVASTATIN IN LOW HDL IN DIABETES TRIAL OF EFFICACY (SILHOUETTE)
(PRINCIPAL INVESTIGATOR, 2001)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, "FACTORIAL" DESIGN, 48 WEEK EXTENSION STUDY TO EVALUATE THE SAFETY OF SCH 58235 10 MG/DAY COADMINISTERED WITH MULTIPLE DOSES OF SIMVASTATIN IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA (EXTENSION)
(PRINCIPAL INVESTIGATOR 2001)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, "FACTORIAL" DESIGN, 12 WEEK STUDY TO EVALUATE THE EFFICACY OF SCH 58235 10 MG/DAY COADMINISTERED WITH MULTIPLE DOSES OF SIMVASTATIN IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR 2001)

A DOSE-RANGING STUDY OF NK-104 IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR 2001)

A DOSE-RANGING STUDY OF NK-104 IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA - SLIT LAMP EXAMINATION SUB-STUDY
(PRINCIPAL INVESTIGATOR 2001)

DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING TRIAL TO EVALUATE THE EFFICACY OF ATORVASTATIN ON BONE MINERAL DENSITY AND MARKERS FOR BONE TURNOVER IN POSTMENOPAUSAL WOMEN WITH DYLIPIDEMIA AND AT RISK FOR OSTEOPOROSIS
(PRINCIPAL INVESTIGATOR 2001)

EFFECTS OF ORAL NO-1886 ON LIPOPROTEINS IN SUBJECTS WITH TYPE II DIABETES MELLITUS WHO ARE RECEIVING STATIN THERAPY
(PRINCIPAL INVESTIGATOR, 2001)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF SD-5613 AS MONOTHERAPY IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA (MONOTHERAPY ASSESSMENT OF REDUCING CHOLESTEROL) [MONARCH].
(PRINCIPAL INVESTIGATOR 2001)

A 16-WEEK, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFECT OF AVASIMIBE IN COMBINATION WITH ATORVASTATIN ON LIPIDS IN PATIENTS WITH TYPE IIA AND IIB DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 2000)

LONG-TERM, OPEN-LABEL, SAFETY STUDY WITH SD-5613
(PRINCIPAL INVESTIGATOR, 2000)

AN EIGHT WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER STUDY IN HYPERCHOLESTEROLEMIC PATIENTS TO DETERMINE THE EFFICACY AND SAFETY OF COMBINATION THERAPY WITH CI-1027 AND A STATIN
(PRINCIPAL INVESTIGATOR, 2000)

PRAVASTATIN OR ATORVASTATIN EVALUATION AND INFECTION THERAPY (PROVE IT)
(PRINCIPAL INVESTIGATOR, 2000)

A PHASE III DOUBLE-BLIND EFFICACY AND SAFETY STUDY OF SCH 58235 (10MG) IN ADDITION TO ATORVASTATIN COMPARED TO PLACEBO IN SUBJECTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2000)

PHASE II, MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF THE SAFETY, EFFICACY, AND TOLERABILITY OF ORAL CP - 529,414 SOFT-GEL CAPSULES IN SUBJECTS WITH LOW HIGH DENSITY LIPOPROTEIN CHOLESTEROL
(PRINCIPAL INVESTIGATOR, 2000)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL, 28 WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SIMVASTATIN 80 MG/DAY VERSUS ATORVASTATIN 80 MG/DAY IN PATIENTS WITH HYPERCHOLESTEROLEMIA (CHESS: COMPARATIVE HDL EFFICACY AND SAFETY STUDY)
(PRINCIPAL INVESTIGATOR, 2000)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO ASSESS THE EFFICACY AND SAFETY OF GL262570 SODIUM TABLETS (2.5 MG, 5 MG, AND 7.5 MG) ADMINISTERED AS A DAILY DOSE FOR 8 WEEKS IN SUBJECTS WITH DYSLIPIDEMIA.

(PRINCIPAL INVESTIGATOR, 2000)

AN OPEN-LABEL, RANDOMIZED STUDY OF THE RELATIVE EFFICACY OF NICOSTATIN COMPARED TO SIMVASTATIN AND ATORVASTATIN
(PRINCIPAL INVESTIGATOR, 2000)

A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, DOSE-RANGING STUDY OF SD-5613 AS MONOTHERAPY AND IN COMBINATION THERAPY WITH ATORVASTATIN (ASSESSMENT OF CHOLESTEROL REDUCTION BY AN INHIBITOR OF THE ILEAL BILE ACID TRANSPORTER SD-5613 (ACRIIBAT)
(PRINCIPAL INVESTIGATOR, 2000)

A MULTICENTER, DOUBLE-BLIND, PARALLEL, 48-WEEK EXTENSION, 3-ARM STUDY TO EVALUATE THE EFFICACY AND SAFETY OF L-654969 IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2000)

WELCHOL LECTURE BUREAU CHART REVIEW PROGRAM
(PRINCIPAL INVESTIGATOR 2000)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO- AND ACTIVE-COMPARATOR-CONTROLLED, PARALLEL STUDY TO EVALUATE THE LIPID-ALTERING EFFICACY, SAFETY, AND TOLERABILITY OF L-410198 IN PATIENTS WITH MIXED HYPERLIPIDEMIA (ELEVATED CHOLESTEROL AND TRIGLYCERIDES)

(PRINCIPAL INVESTIGATOR, 2000)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL, 12-WEEK, 4-ARM STUDY TO EVALUATE THE EFFICACY AND SAFETY OF L-654969 IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2000)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL OF ONCE PER DAY VS. SPLIT DOSING OF SEVELAMER HYDROCHLORIDE IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 2000)

AN OPEN-LABEL, MULTINATIONAL, MULTICENTRE, EXTENSION TRIAL TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF ZD4522 IN SUBJECTS IN THE ZD4522 CLINICAL TRIAL PROGRAM
(PRINCIPAL INVESTIGATOR, 1999)

A 12 WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER STUDY TO DETERMINE THE EFFICACY AND SAFETY OF CI-1027 IN PATIENTS WITH LOW HDL-C AND EITHER NORMAL OR ELEVATED TRIGLYCERIDES
(PRINCIPAL INVESTIGATOR, 1999)

LONG TERM, OPEN-LABEL, SAFETY AND TOLERABILITY STUDY OF SCH 58235 IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA (EXTENSION)
(PRINCIPAL INVESTIGATOR, 1999)

DOSE-RESPONSE EFFECTS OF ORAL NO-1886 ON LIPOPROTEINS IN SUBJECTS WITH DECREASED HDL-C LEVELS
(PRINCIPAL INVESTIGATOR, 1999)

PHASE II, DOSE-RESPONSE STUDY OF ORAL NO-1886 IN SUBJECTS WITH MARKED HYPERTRIGLYCERIDEMIA
(PRINCIPAL INVESTIGATOR, 1999)

A COMPARATIVE STUDY OF LOVASTATIN XL WITH MEVACOR IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1999)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, PILOT STUDY TO ASSESS THE 4-WEEK SAFETY AND EFFICACY OF ORAL 264W94 ADMINISTERED AS MONOTHERAPY (8 MG BID, 32 MG BID) AND COMBINATION THERAPY (8MG BID PLUS 20 MG ZOCOR QD) IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1999)

A SIX WEEK, RANDOMIZED DOUBLE-BLIND MULTICENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ZD4522 (5, 10, 20, 40, AND 80 MG) AND ATORVASTATIN (10, 20, 40, AND 80 MG) ACROSS THEIR RESPECTIVE DOSE RANGES IN THE TREATMENT OF SUBJECTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1999)

A TWELVE WEEK MULTICENTER RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ZD4522 (5,10,20,40 AND 80 MG) IN THE TREATMENT OF SUBJECTS WITH HYPERTRIGLYCERIDEMIA
(PRINCIPAL INVESTIGATOR, 1999)

A PHASE III, DOUBLE BLIND, EFFICACY AND SAFETY STUDY OF ONE DOSE OF SCH 58235 10MG COMPARED TO PLACEBO IN SUBJECTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1999)

AN EXTENDED SAFETY, EFFICACY AND TOLERABILITY STUDY OF LOVASTATIN XL IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1999)

CERIVASTATIN FOR HYPERLIPIDEMIA AFTER REACHING MENOPAUSE (CHARM): A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP, 6 -WEEK EVALUATION OF CERIVASTATIN 0.4 MG AND ATORVASTATIN 10 MG IN POST MENOPAUSAL WOMEN WITH HYPERLIPIDEMIA AND A 46 WEEK EVALUATION IN WHICH CERIVASTATIN 0.4 MG AND CERIVASTATIN 0.8 MG ARE COMPARED TO FENOFIBRATE 201 MG FOR LONG-TERM LIPID-LOWERING AND BONE MINERAL DENSITY EFFECTS.
(PRINCIPAL COINVESTIGATOR, 1999)

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER TRIAL TO COMPARE THE SHORT-TERM AND LONG-TERM EFFICACY AND SAFETY OF ZD4522, SIMVASTATIN, AND PRAVASTATIN IN THE TREATMENT OF SUBJECTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1999)

A PHASE II DOUBLE BLIND DOSE RESPONSE INVESTIGATION OF THE EFFICACY AND SAFETY OF FOUR DOSES OF SCH 58235 COMPARED TO PLACEBO IN SUBJECTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1999)

A STUDY TO EVALUATE THE DEGREE OF CORRELATION BETWEEN HEPATIC ULTRASOUND, COMPUTED TOMOGRAPHY AND MAGNETIC RESONANCE IMAGING AS METHODS TO DETECT POTENTIAL FAT INFILTRATION OF THE LIVER FOLLOWING 80 AND 160 MG BAY 13-9952, OR PLACEBO DOSED ONCE DAILY FOR 28 DAYS IN HYPERCHOLESTEROLEMIC PATIENTS.
(PRINCIPAL INVESTIGATOR, 1999)

A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP EVALUATION OF CERIVASTATIN 0.8 MG COMPARED TO CERIVASTATIN 0.4 AND PLACEBO ONCE DAILY IN PATIENTS WITH HYPERTRIGLYCERIDEMIA
(PRINCIPAL INVESTIGATOR, 1999)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL OF GT 102-279 ALONE AND IN COMBINATION WITH LOVASTATIN IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1999)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, 2 PERIOD, COMPLETE BLOCK, CROSSOVER STUDY TO EVALUATE THE EFFICACY OF L-654969 AND SIMVASTATIN IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1999)

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL, 36 WEEK DOSE ESCALATION STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SIMVASTATIN 40 AND 80 MG/DAY VERSUS ATORVASTATIN 20, 40, AND 80 MG/DAY IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1998)

A LONG-TERM, OPEN-LABEL, MULTI-CENTER TRIAL OF THE SAFETY AND EFFICACY OF NICOSTATIN IN PATIENTS WITH DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 1998)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF COLESEVELAM HYDROCHLORIDE AND SIMVASTATIN ALONE AND IN COMBINATION IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1998)

EFFICACY COMPARISON OF DIFFERENT FORMULATIONS OF PRAVASTATIN 40MG
(PRINCIPAL INVESTIGATOR, 1998)

A RANDOMIZED, DOUBLE-BLIND, PARALLEL, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY OF SIMVASTATIN IN THERAPY IN PATIENTS WITH HYPERTRIGLYCERIDEMIA
(PRINCIPAL INVESTIGATOR, 1998)

A 54 WEEK OPEN LABEL ASSESSMENT OF THE SAFETY AND EFFICACY PROFILE OF ATORVASTATIN AS COMPARED TO FLUVASTATIN, LOVASTATIN, SIMVASTATIN, AND PRAVASTATIN WHEN USED TO OPTIMALLY CONTROL PRIMARY HYPERCHOLESTEROLEMIA (IIA) AND MIXED DYSLIPIDEMIA (TYPE IIB)
(PRINCIPAL INVESTIGATOR, 1997)

PILOT DOSE-RANGING STUDY OF THE SAFETY AND EFFICACY OF SCH 58235 COMPARED TO PLACEBO AND LOVASTATIN IN PATENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1997)

SCREENING PROCEDURE FOR IDENTIFICATION OF SUBJECTS FOR PARTICIPATION IN A PILOT DOSE-RANGING STUDY OF THE SAFETY AND EFFICACY OF SCH 58235 COMPARED TO PLACEBO AND LOVASTATIN IN PATENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1997)

A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP EVALUATION OF CERIVASTATIN 0.8 MG COMPARED TO CERIVASTATIN 0.4 MG
AND PLACEBO/PRAVASTATIN 40 MG ONCE DAILY IN PATENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1997)

A RANDOMIZED, DOUBLE-BLIND TRIAL OF CHOLESTAGEL (2.4G, 3.2G, 4.0G, 4.8G) VS PLACEBO IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1997)

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FOUR-PERIOD BALANCED CROSSOVER STUDY TO EVALUATE THE EFFICACY OF SIMVASTATIN THERAPY IN PATIENTS WITH COMBINED HYPERLIPIDEMIA
(PRINCIPAL INVESTIGATOR, 1997)

A DOUBLE-BLIND, MULTI-CENTER STUDY OF THE SAFETY AND EFFICACY OF NIASPAN (CONTROLLED-RELEASE NIACIN) VERSUS GEMFIBROZIL PATIENTS WITH LOW LEVELS OF HIGH-DENSITY LIPOPROTEIN (HDL) CHOLESTEROL
(PRINCIPAL INVESTIGATOR, 1997)

A FOUR YEAR, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF ATORVASTATIN AS PREVENTION OF CHD IN PATIENTS WITH TYPE II NONINSULIN-DEPENDENT DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR, 1996)

MULTICENTER, DOUBLE-BLIND, 4-ARM, PARALLEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SIMVASTATIN GEM 80 AND 160 MG IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1996)

MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL STUDY TO DETERMINE THE LDL-C LOWERING EFFICACY OF PRAVASTATIN ADMINISTERED ONCE DAILY OVER THE DOSAGE RANGE OF 40MG THOROUGH 160 MG
(PRINCIPAL INVESTIGATOR, 1996)

RESEARCH COMPLETED TRIALS MULTICENTER, DOUBLE BLIND, TWO-ARM, PARALLEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF HIGH DOSE SIMVASTATIN IN HYPERCHOLESTEROLEMIC PATIENTS - EXTENSION STUDY
(PRINCIPAL INVESTIGATOR, 1996)

MULTICENTER, DOUBLE-BLIND, 2-ARM, PARALLEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF HIGH-DOSE SIMVASTATIN IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1996)

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFECTS OF SIMVASTATIN 80 MG A DAY ON STEROID HORMONE PRODUCTION IN MEN
(PRINCIPAL INVESTIGATOR, 1996)

PILOT EVALUATION OF THE PHARMACOKINETICS OF NICOTINIC ACID AND ITS MAJOR METABOLITES FOLLOWING MULTIPLE DOSE ADMINISTRATION OF NIACOR-SR
(PRINCIPAL INVESTIGATOR, 1996)

A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP EVALUATION OF CERIVASTATIN COMPARED TO FLUVASTATIN 40MG AND PLACEBO DAILY IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR, 1996)

EXTENDED ACCESS TREATMENT PROTOCOL FOR THE USE OF ATORVASTATIN IN PATIENTS WHO PARTICIPATED IN PRIOR PROTOCOLS
(PRINCIPAL INVESTIGATOR, 1996)

ATORVASTATIN/DIABETES EXTENSION STUDY
(PRINCIPAL INVESTIGATOR, 1995)

MULTICENTER, OPEN-LABEL, TRIAL OF THE LONG-TERM SAFETY AND EFFICACY OF NIASPAN IN PATIENTS WITH PRIMARY HYPERLIPOPROTEINEMIA
(PRINCIPAL INVESTIGATOR 1994)

THE NIACIN STUDY - NIACOR-SR VS. IMMEDIATE RELEASE NIACIN
(PRINCIPAL INVESTIGATOR 1994)

LONGTERM SAFETY AND EFFICACY OF NIACOR-SR TABLETS IN THE TREATMENT OF HYPERLIPIDEMIA
(PRINCIPAL INVESTIGATOR 1994)

A PLACEBO-CONTROLLED, DOUBLE-BLIND, PARALLEL GROUP 6-MONTH STUDY OF THE EFFECT OF CERIVASTATIN COMPARED TO LOVASTATIN 40 MG ONCE DAILY ON SEMEN PRODUCTION AND ADRENAL AND REPRODUCTIVE HORMONE FUNCTION IN MALE PATIENTS WITH HYPERCHOLESTEROLEMIA.
(PRINCIPAL INVESTIGATOR 1994)

A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, 6-WEEK, DOSE-RANGING STUDY OF ONCE DAILY ATORVASTATIN IN PATIENTS WITH ELEVATED LDL-CHOLESTEROL.
(PRINCIPAL INVESTIGATOR, 1994)

MULTI-CENTER QUALIFICATION TRIAL FOR ENTRY INTO THE MULTI-CENTER, OPEN-LABEL TRIAL OF THE LONG-TERM SAFETY AND EFFICACY OF NIASPAN IN PATIENTS WITH PRIMARY HYPERLIPOPROTEINEMIA
(PRINCIPAL INVESTIGATOR 1994)

NIACIN DIET TRIAL
(PRINCIPAL INVESTIGATOR 1994)

DOUBLE BLIND STUDY OF A ATORVASTATIN COMPARED TO SIMVASTATIN IN LOWERING CHOLESTEROL IN PATIENTS WITH NON-INSULIN DEPENDENT DIABETES MELLITUS PATIENTS WITH DYSLIPIDEMIA
(PRINCIPAL INVESTIGATOR 1994)

FIRST EXTENSION DOUBLE BLIND DOSE-RANGING STUDY OF CERIVASTATIN IN DOSES OF 25UG, 50UG, 100UG, AND 200UG ONCE DAILY COMPARED TO PLACEBO AND TO LOVASTATIN 40MG ONCE DAILY IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR 1993)

SECOND EXTENSION DOUBLE BLIND DOSE-RANGING STUDY OF CERIVASTATIN IN DOSES OF 25UG, 50UG, 100UG, AND 200UG ONCE DAILY COMPARED TO PLACEBO AND TO LOVASTATIN 40MG ONCE DAILY IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR 1993)

THIRD EXTENSION DOUBLE BLIND DOSE-RANGING STUDY OF CERIVASTATIN IN DOSES OF 25UG, 50UG, 100UG, AND 200UG ONCE DAILY COMPARED TO PLACEBO AND TO LOVASTATIN 40MG ONCE DAILY IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR 1993)

A PHASE II PIVOTAL STUDY TO EVALUATE EFFICACY AND SAFETY OF SCH 48461 IN SUBJECTS WITH HYPERCHOLESTEROLEMIA.
(PRINCIPAL INVESTIGATOR 1993)

OPEN-LABEL STUDY OF FLUVASTATIN IN THE TREATMENT OF PATIENTS WITH HYPERCHOLESTEROLEMIA IN CLINICAL PRACTICE SETTINGS
(PRINCIPAL INVESTIGATOR 1993)

DOUBLE BLIND DOSE-RANGING STUDY OF CERIVASTATIN IN DOSES OF 25UG, 50UG, 100UG, AND 200UG ONCE DAILY COMPARED TO PLACEBO AND TO LOVASTATIN 40MG ONCE DAILY IN PATIENTS WITH HYPERCHOLESTEROLEMIA
(PRINCIPAL INVESTIGATOR 1992)

PRAVASTATIN ENDOCRINE STUDY IN MEN
PRINCIPAL INVESTIGATOR (1992)

PRAVASTATIN ENDOCRINE STUDY IN WOMEN
(PRINCIPAL INVESTIGATOR 1992)

CHOLESTEROL SEQUESTRANT PHASE II STUDY
(CO-INVESTIGATOR 1992)

LIFIBROL (A NOVEL CHOLESTEROL LOWERING AGENT) DOSE-RANGING STUDY IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
PRINCIPAL INVESTIGATOR (1992)

PRAVASTATIN SPECIAL PATIENT POPULATION STUDY
PRINCIPAL INVESTIGATOR (1992)

R.E.M. (RESIN ENROBED METHOCEL) I STUDY
(PRINCIPAL INVESTIGATOR 1991)

R.E.M. (RESIN ENROBED METHOCEL) II STUDY
(PRINCIPAL INVESTIGATOR 1991)

L.A.S. (LOVASTATIN ADOLESCENT STUDY) STUDY
CO-INVESTIGATOR (1991)

S.E.L.E.C.T. (SELECOR'S EFFECT LOWERING BP IN THOSE WITH ELEVATED CHOLESTEROL/TRIGLYCERIDES) STUDY
(PRINCIPAL INVESTIGATOR 1991)

Migraines

A phase 4, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of galcanezumab versus rimegepant in adult participants with episodic migraine
(PRINCIPAL INVESTIGATOR, 2022)

A PHASE 2/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL ZAVEGEPANT IN MIGRAINE PREVENTION
(PRINCIPAL INVESTIGATOR, 2021)

BHV3500-301: PHASE 3: DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, SAFETY AND EFFICACY TRIAL OF BHV3500 (ZAVEGEPANT) INTRANASAL (IN) FOR THE ACUTE TREATMENT OF MIGRAINE
(PRINCIPAL INVESTIGATOR, 2021)

A RANDOMIZAED, DOUBLE- BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF STS101 (DIHYDROERGOTAMINE NASAL POWDER) IN ACUTE TREATMENT OF MIGRAINE
(PRINCIPAL INVESTIGATOR, 2021)

A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GALCANEZUMAB VERSUS RIMEGEPANT IN ADULT PARTICIPANTS WITH EPISODIC MIGRAINE
(PRINCIPAL INVESTIGATOR, 2021)

AN OPEN-LABEL STUDY TO ASSESS THE LONG-TERM SAFETY OF AXS-07 (MELOXICAM AND RIZATRIPTAN) FOR THE ACUTE TREATMENT OF MIGRAINE IN ADULTS
(PRINCIPAL INVESTIGATOR 2020)

A RANDOMIZED, DOUBLE-BLIND, SINGLE DOSE, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF AXS-07 (MELOXICAM AND RIZATRIPTAN) FOR THE ACUTE TREATMENT OF MIGRAINE IN ADULTS
(PRINCIPAL INVESTIGATOR, 2019)

MOMENTUM (MAXIMIZING OUTCOMES IN TREATING ACUTE MIGRAINE): A RANDOMIZED, DOUBLE-BLIND, SINGLE-DOSE, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF AXS-07 (MELOXICAM AND RIZATRIPTAN) FOR THE ACUTE TREATMENT OF MIGRAINE IN ADULTS
(PRINCIPAL INVESTIGATOR, 2018)

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE LONGTERM SAFETY AND TOLERABILITY OF ORAL ATOGEPANT FOR THE PREVENTION OF MIGRAINE IN PATIENTS WITH EPISODIC MIGRAINE
(PRINCIPAL INVESTIGATOR, 2018)

A MULTICENTER, RANDOMIZED, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF ORAL UBROGEPANT IN THE ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA.
(PRINCIPAL INVESTIGATOR, 2016)

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED SINGLE ATTACK STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF ORAL UBROGEPANT IN THE ACUTE TREATMENT OF MIGRAINE (PRINCIPAL (PRINCIPAL INVESTIGATOR, 2016)

DR. REDDY LABORATORIES, LTD. : A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY, TOLERABILITY, AND SAFETY STUDY OF DFN-15 IN EPISODIC MIGRAINE WITH OR WITHOUT AURA
(PRINCIPLE INVESTIGATOR, 2016)

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF LY2951742 IN PATIENTS WITH EPISODIC MIGRAINE – THE EVOLVE-1 STUDY
(PRINCIPAL INVESTIGATOR, 2015)

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AMG 334 IN MIGRAINE PREVENTION
(PRINCIPAL INVESTIGATOR, 2014)

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AMG 334 IN MIGRAINE PREVENTION
(PRINCIPAL INVESTIGATOR 2013)

A PHASE IIB, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-FINDING STUDY OF MK-1602 IN THE TREEATMENT OF ACUTE MIGRAINE
(PRINCIPAL INVESTIGATOR 2012)

A WORLDWIDE, OPEN LABEL, CLINICAL TRIAL TO EXAMINE THE LONG TERM SAFETY AND TOLERABILITY OF RIZATRIPTAN IN PEDIATRIC MIGRAINEURS 12 TO 17 YEARS OF AGE FOR THE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA.
(PRINCIPAL INVESTIGATOR 2010)

A WORLDWIDE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF RIZATRIPAN FOR THE ACUTE TREATMENT OF MIGRAINE IN CHILDREN AND ADOLESCENTS.
(PRINCIPAL INVESTIGATOR 2010)

A PHASE IIA, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF MK-0974 FOR MIGRAINE PROPHYLAXIS IN PATIENTS WITH EPISODIC MIGRAINE.
(PRINCIPAL INVESTIGATOR 2009)

A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP MULTIPLE ATTACKS STUDY TO COMPARE THE EFFICACY AND SAFETY OF ORAL MK-0974 WITH PLACEBO FOR THE ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
(PRINCIPAL INVESTIGATOR 2008)

A MULTICENTER, DOUBLE-BLIND, PLACEBO AND ACTIVE-CONTROLLED, PARALLEL GROUP STUDY TO COMPARE THE EFFICACY AND SAFETY OF ORAL MK-0974 WITH PLACEBO AND ZOLMITRIPTAN FOR THE ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
(PRINCIPAL INVESTIGATOR 2007)

A MULTICENTER, DOUBLE-BLIND, ACTIVE-CONTROLLED, PARALLEL GROUP STUDY TO EXAMINE THE SAFETY, TOLERABILITY AND EFFICACY OF ORAL MK-0974 FOR THE LONG TERM TREATMENT OF ACUTE MIGRAINE WITH OR WITHOUT AURA
(PRINCIPAL INVESTIGATOR 2007)

Fatty liver (MASLD/NAFLD)

A phase 2b, multicenter, randomized, double-blind, placebo-controlled study of HTD1801 in adult subjects with nonalcoholic steatohepatitis (NASH) and liver fibrosis who have type 2 diabetes or pre-diabetes
(PRINCIPAL INVESTIGATOR, 2023)

A 52-WEEK, PHASE 3 OPEN-LABEL EXTENSION STUDY, WITH A SINGLE-BLIND LEAD IN, TO EVALUATE THE SAFETY AND BIOMARKERS OF RESMETIROM (MGL 3196) IN PATIENTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD), MAESTRO-NAFLD-OPEN-LABEL-EXTENSION (MAESTRO-NAFLD-OLE)
(PRINCIPAL INVESTIGATOR-2021)

A 52-WEEK, PHASE 3 STUDY TO EVALUATE THE SAFETY AND BIOMARKERS OF RESMETIROM (MGL 3196) IN PATIENTS WITH NON-ALCOHLIC FATTY LIVER DISEASE
(PRINCIPAL INVESTIGATOR, 2020)

A PHASE 2A, 2-PART, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY PLACEBO-CONTROLLED, PARALLEL-GROUP (SPONSOR OPEN) STUDY TO ASSESS PHARMACODYNAMICS AND SAFETY OF PF-06865571 (DGAT2I) COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH PRESUMED NONALCOHOLIC STEATOHEPATITIS (NASH)
(PRINCIPAL INVESTIGATOR, 2020)

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND (SPONSOR-OPEN), PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-05221304 AND PF-06865571 CO-ADMINISTERED FOR 6 WEEKS IN ADULTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD)
(PRINCIPAL INVESTIGATOR, 2019)

Arthritis, Gout, Osteoporosis, Pain

A multicentre randomized, double-blind, placebo-controlled, dose finding, phase 2 study (MARS-17) of GSK3858279 in adult participants with moderate to severe pain due to knee osteoarthritis
(PRINCIPAL INVESTIGATOR, 2023)

A randomized, multi-regional, double-blind, parallel-group, placebo-controlled phase 3 study to assess the safety and efficacy of 6 months treatment with tigulixostat in gout patients with hyperuricemia
(PRINCIPAL INVESTIGATOR, 2022)

A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF SEL-212 IN PATIENTS WITH GOUT REFRACTORY TO CONVENTIONAL THERAPY.
(PRINCIPAL INVESTIGATOR, 2020).

A STUDY TO COMPARE THE EFFICACY OF SEL-212 TO KYRSTEXXA IN GOUT PATIENTS REFRACTORY TO CONVENTIONAL THERAPY
(PRINCIPAL INVESTIGATOR, 2019)

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, PLACEBO AND NSAID-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FASINUMAB IN PATIENTS WITH PAIN DUE TO OSTEOARTHRITIS OF THE KNEE OR HIP
(PRINCIPAL INVESTIGATOR, 2018)

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, 3-STAGE, EFFICACY AND SAFETY STUDY OF NI-071 AND US-LICENSED REMICADE® (INFLIXIMAB) FOR THE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS
(PRINCIPAL INVESTIGATOR, 2016)

AN OPEN LABEL PHASE II MULTIPLE DOSE SAFETY, PHARMACOKINETIC AND PHARMACODYNAMICS STUDY OF SEL-212 FOLLOWED BY OPEN LABEL ADMINISTRATION OF SEL-037 IN SUBJECTS WITH SYMPTOMATIC GOUT AND ELEVATED BLOOD URIC ACID.
(PRINCIPAL INVESTIGATOR, 2016)

A PHASE 3 DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF NKTR-181 IN OPIOID-NAÏVE SUBEJCTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN
(PRINCIPAL INVESTIGATOR, 2015)

A PHASE 3 MULTICENTER, OPEN-LABEL, 52-WEEK STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF NKTR-181 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN OR CHRONIC NONCANCER PAIN
(PRINCIPAL INVESTIGATOR, 2015)

A MULTICENTER, RANDOMIZED, ACTIVE-CONTROL, PHASE 3B STUDY TO EVALUATE THE CARDIOVASCULAR SAFETY AND EFFICACY OF FEBUXOSTAT AND ALLOPURINOL IN SUBJECTS WITH CARDIOVASCULAR COMORBIDITIES, HYPERURICEMIA, AND GOUT.
(PRINCIPAL INVESTIGATOR, 2015)

A RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ARHALOFENATE FOR PREVENTING FLARES AND REDUCING SERUM URIC ACID IN GOUT PATIENTS
(PRINCIPAL INVESTIGATOR, 2014)

A PHASE 3 RANDOMIZED, DOUBLE BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FEBUXOSTAT 40 MG XR, 80 MG XR, 40 MG IR, AND 80 MG IR IN SUBJECTS WITH GOUT
(PRINCIPAL INVESTIGATOR, 2014)

A PHASE 2, ENRICHED-ENROLLMENT, RANDOMIZED-WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY, TOLERABILITY, AND SAFETY OF NKTR-181 IN OPIOID-NAIVE SUBJECTS WITH MODERATE TO SEVERE CHRONIC PAIN DUE TO OSTEOARTHRITIS OF THE KNEE
(PRINCIPAL INVESTIGATOR, 2013)

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LESINURAD MONOTHERAPY COMPARED TO PLACEBO IN SUBJECTS WITH GOUT AND AN INTOLERANCE OR CONTRAINDICATION TO XANTHINE OXIDASE INHIBITOR (LIGHT)
(PRINCIPAL INVESTIGATOR, 2012)

LONG-TERM ALLOPURINOL SAFETY STUDY EVALUATING OUTCOMES IN GOUT PATIENTS (LASSO)
(PRINCIPAL INVESTIGATOR, 2011)

A MULTICENTER, RANDOMIZED, ACTIVE-CONTROL, PHASE 3B STUDY TO EVALUATE THE CARDIOVASCULAR SAFETY OF FEBUXOSTAT AND ALLOPURINOL IN SUBJECTS WITH GOUT AND CARDIOVASCULAR COMORBIDITIES.
(PRINCIPAL INVESTIGATOR, 2010)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF JNJ-42160443 AS ADJUNCTIVE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE KNEE OR HIP PAIN FROM OSTEOARTHRITIS.
(PRINCIPAL INVESTIGATOR, 2010)

A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
(PRINCIPAL INVESTIGATOR, 2010)

A PHASE 3 RANDOMIZED, DOUBLE-BLIND PLACEBO AND NAPROXEN CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
(PRINCIPAL INVESTIGATOR, 2010)

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECT OF A SINGLE INJECTION OF SAR164877 (REGN475) ON REDUCTION OF PAIN FROM VERTEBRAL FRACTURE ASSOCIATED WITH OSTEOPOROSIS
(PRINCIPAL INVESTIGATOR, 2010)

A PHASE 3, 53 WEEKS STUDY ON ANALGESIC EFFICACY AND SAFETY OF NAPROXICINOD (HCT 3012): 26 WEEK, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO (13 WEEKS) AND NAPROXEN (26 WEEKS) CONTROLLED, MULTICENTER STUDY OF NAPROXICINOD (375 MG BID AND 750 MG BID) WITH A 26 WEEK NAPROXEN-CONTROLLED SAFETY FOLLOW-UP IN SUBJECTS WITH OSEOARTHRITIS OF THE KNEE AND A 1 WEEK POST TREATMENT SAFETY FOLLOW-UP.
(PRINCIPAL INVESTIGATOR, 2009)

A RANDOMIZED, DOUBLE-BLIND PLACEBO CONTROLLED TRIAL OF [S,S]-REBOXETINE IN PATIENTS WITH CHRONIC PAINFUL DIABETIC PERIPHERAL NEUROPATHY
(PRINCIPAL INVESTIGATOR, 2008)

A MULTI-CENTER, LONG-TERM, OPEN-LABEL EXTENSION STUDY OF [S,S]-REBOXETINE (PNU-165442G) ADMINISTERED ONCE DAILY IN PATIENTS WITH FIBROMYALGIA
(PRINCIPAL INVESTIGATOR, 2008)

A 14-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY OF [S,S]-REBOXETINE (PNU-165442G) ADMINISTERED ONCE DAILY (QD) IN PATIENTS WITH FIBROMYALGIA
(PRINCIPAL INVESTIGATOR 2008)

A MULTICENTER, RANDOMIZED, CROSS-OVER, OPEN-LABEL STUDY TO EVALUATE THE ADHERENCE, PREFERENCE, AND SATISFACTION OF DENOSUMAB AND ALENDRONATE IN POSTMENOPAUSAL WOMEN WITH LOW BONE MINERAL DENSITY.
(PRINCIPAL INVESTIGATOR, 2007)

A LONG-TERM, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED, RADIOGRAPHIC STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF ORALLY ADMINISTERED SD-6010 IN SUBJECTS WITH SYMPTOMATIC OSTEOARTHRITIS OF THE KNEE
(PRINCIPAL INVESTIGATOR, 2007)

A PHASE III RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF ODANACATIB (MK-0822) TO REDUCE THE RISK OF FRACTURE IN OSTEOPOROTIC POSTMENOPAUSAL WOMEN TREATED WITH VITAMIN D AND CALCIUM
(PRINCIPAL INVESTIGATOR, 2007)

A PHASE III, VARIABLE-DOSE TITRATION FOLLOWED BY A RANDOMIZED DOUBLE-BLIND STUDY OF CONTROLLED-RELEASE OROS HYDROMORPHONE HCL (NMED-1077) COMPARED TO PLACEBO IN PATIENTS WITH CHRONIC LOW BACK PAIN
(PRINCIPAL INVESTIGATOR, 2007)

A RANDOMIZED, DOUBLE BLIND, PARALLEL-GROUP STUDY OF CARDIOVASCULAR SAFETY IN OSTEOARTHRITIS OR RHEUMATOID ARTHRITIS PATIENTS WITH OR AT HIGH RISK FOR CARDIOVASCULAR DISEASE COMPARING CELECOXIB WITH NAPROXEN AND IBUPROFEN
(PRINCIPAL INVESTIGATOR, 2007)

A TWO WEEK,RANDOMIZED,DOUBLE BLIND,PLACEBO AND POSITIVE CONTROLLED,PARALLEL GROUP,MULTICENTRE STUDY TO ASSESS THE EFFICACY AND TOLERABILITY OF PF-00592379 IN PATIENTS WITH MODERATE TO SEVERE PAIN DUE TO OSTEOARTHRITIS.
(PRINCIPAL INVESTIGATOR, 2007)

A PHASE 3, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, ALLOPURINOL-CONTROLLED STUDY ASSESSING THE EFFICACY AND SAFETY OF ORAL FEBUXOSTAT IN SUBJECTS WITH GOUT
(PRINCIPAL INVESTIGATOR, 2007)

A PHASE 3, 53 WEEKS STUDY ON ANALGESIC EFFICACY AND SAFETY OF NAPROXICINOD (HCT 3012): 26-WEEK, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO (13 WEEKS)- AND NAPROXEN (26 WEEKS)-CONTROLLED, MULTICENTER STUDY OF NAPROXICINOD (375MG BID AND 750MG BID) WITH A 26-WEEK NAPROXEN-CONTROLLED SAFETY FOLLOW-UP IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE, AND A 1-WEEK POST-TREATMENT SAFETY FOLLOW-UP
(PRINCIPAL INVESTIGATOR, 2007)

PRECISION: PROSPECTIVE, RANDOMIZED EVALUATION OF CELECOXIB INTEGRATED SAFETY VS IBUPROFEN OR NAPROXEN
(PRINCIPAL INVESTIGATOR, 2007)

A PHASE III, 12 WEEK, MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, PLACEBO- AND ACTIVE COMPARATOR-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GW406381, 5MG, 10MG, 25MG, AND 50MG ADMINISTERED ORALLY ONCE DAILY, IN ADULTS WITH RHEUMATOID ARTHRITIS.
(PRINCIPAL INVESTIGATOR, 2006)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-AND POSITIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF ORAL DOSES OF CJ-023,423 ADMINISTERED FOR 4 WEEKS TO SUBJECTS WITH OSTEOARTHRITIC PAIN OF THE KNEE.
(PRINCIPAL INVESTIGATOR, 2006)

A PHASE 3, RANDOMIZED, MULTICENTER, DOUBLE-BLIND STUDY COMPARING THE ANALGESIC EFFICACY OF EXTENDED RELEASE HYDROCODONE/ACETAMINOPHEN TABLETS (VICODIN CR) TO PLACEBO IN SUBJECTS WITH OSTEOARTHRITIS
(PRINCIPAL INVESTIGATOR, 2006)

EFFECTS OF ARZOXIFENE ON VERTEBRAL FRACTURE INCIDENCE AND ON INVASIVE BREAST CANCER INCIDENCE IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS OR WITH LOW BONE DENSITY WITHOUT OSTEOPOROSIS
(PRINCIPAL INVESTIGATOR, 2005)

A 4-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF L-000904218
IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
(PRINCIPAL INVESTIGATOR, 2005)

A 12-WEEK RANDOMIZED, PLACEBO- AND ACTIVE-COMPARATOR-CONTROLLED, PARALLEL-GROUP, DOUBLE-BLIND STUDY TO ASSESS THE SAFETY AND EFFICACY OF ETORICOXIB 30MG VERSUS IBUPROFEN 2400MG IN PATIENTS WITH OSTEOARTHRITIS.
(PRINCIPAL INVESTIGATOR, 2004)

A 26-WEEK, RANDOMIZED, PLACEBO- AND ACTIVE-COMPARATOR-CONTROLLED, PARALLEL-GROUP, DOUBLE-BLIND, 2-PART STUDY TO ASSESS THE SAFETY AND EFFICACY OF ETORICOXIB 30MG VERSUS CELECOXIB 200 MG IN PATIENTS WITH OSTEOARTHRITIS.
(PRINCIPAL INVESTIGATOR, 2004)

RANDOMIZED, DOUBLE-BLIND, MULITCENTER, ACTIVE COMPARATOR STUDY TO DETERMINE THE EFFICACY AND SAFETY OF BTDS 20 OR OXYIR VERSUS BTDS 5 IN SUBJECTS WITH MODERATE TO SEVERE OSTEOARTHRITIS (OA) PAIN
(PRINCIPAL INVESTIGATOR, 2004)

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER TO EVALUATE THE TOLERABILITY AND EFFECTIVENESS OF ETORICOXIB 90 MG A DAY VERSUS DICLOFENAC SODIUM 50 MG TID IN PATIENTS WITH OSTEOARTHRITIS
(PRINCIPAL INVESTIGATOR 2003)

A RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY OF ETORICOXIB IN PATIENTS WITH OSTEOARTHRITIS OR RHEUMATOID ARTHRITIS
(PRINCIPAL INVESTIGATOR 2003)

A PHASE II STUDY ON ANALGESIC EFFICACY, SAFETY, AND TOLERABILITY OF AR-P900758XX: A SIX-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-FINDING, MULTI-CENTRE STUDY COMPARING AR-P900758XX WITH VIOXX AND WITH NAPROXEN IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE
(PRINCIPAL INVESTIGATOR, 2002)

DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING TRIAL TO EVALUATE THE EFFICACY OF ATORVASTATIN ON BONE MINERAL DENSITY AND MARKERS FOR BONE TURNOVER IN POSTMENOPAUSAL WOMEN WITH DYSLIPIDEMIA AND AT RISK FOR OSTEOPOROSIS
(PRINCIPAL INVESTIGATOR 2001)

AN 86-WEEK, DOUBLE-BLIND, ACTIVE COMPARATOR-CONTROLLED EXTENSION TO THE 1 - YEAR, RANDOMIZED, PLACEBO- AND ACTIVE COMPARATOR-CONTROLLED, PARALLEL-GROUP, DOUBLE-BLIND, 2 PART STUDY TO ASSESS THE SAFETY AND EFFICACY OF MK-0663 VERSUS IN PATIENTS WITH OSTEOARTHRITIS
(PRINCIPAL INVESTIGATOR, 2000 - 2001)

DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP COMPARISON STUDY OF THE SAFETY OF CELECOXIB VS ROFECOXIB IN TREATED HYPERTENSIVE PATIENTS WITH OSTEOARTHRITIS (SUCCESS VII)
(PRINCIPAL INVESTIGATOR, 2000 - 2001)

A MULTICENTER, RANDOMIZED, PARALLEL-GROUP, ACTIVE- AND PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY CONDUCTED UNDER IN-HOUSE BLINDING CONDITIONS TO DETERMINE THE INCIDENCE OF GASTRODUODENAL ULCERS IN PATIENTS WITH RHEUMATOID ARTHRITIS AFTER 12 WEEKS OF TREATMENT WITH MK-0663, NAPROXEN, OR PLACBO
(PRINCIPAL INVESTIGATOR, 1999 - 2000)

DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP COMPARISON STUDY OF THE SAFETY OF CELECOXIB VS ROFECOXIB IN HYPERTENSIVE PATIENTS WITH PERIPHERAL OSTEOARTHRITIS TAKING ANTIHYPERTENSIVE MEDICATIONS (SUCCESS-VI)
(PRINCIPAL INVESTIGATOR, 1999 - 2000)

A 1-YEAR, RANDOMIZED, PLACEBO- AND ACTIVE-COMPARATOR-CONTROLLED, PARALLEL-GROUP, DOUBLE-BLIND, TWO PART STUDY TO ASSESS THE SAFETY AND EFFICACY OF MK-0663 VERSUS NAPROXEN IN PATIENTS WITH OSTEOARTHRITIS.
(PRINCIPAL INVESTIGATOR, 1999 - 2000)

ASSESSMENT OF DIFFERENCES BETWEEN VIOXX AND NAPROXEN TO ASCERTAIN GASTROINTESTINAL TOLERABILITY AND EFFECTIVENESS (ADVANTAGE) - A RANDOMIZED, DOUBLE BLIND, MULTICENTER STUDY TO EVALUATE THE TOLERABILITY AND EFFECTIVENESS OF ROFECOXIB (MK-0966) 25 MG QD VS NAPROXEN 500 MG BID IN PATIENTS WITH OSTEOARTHRITIS.
(SUBINVESTIGATOR, 1999 - 2000)

DEVELOPMENT AND VALIDATION OF A PREDICTIVE MODEL FOR FACILITATION OF DIAGNOSIS OF LOW BONE MASS IN PERIMENOPAUSAL AND POSTMENOPAUSAL WOMEN
(PRINCIPAL INVESTIGATOR 1994-1995)

Hypertension

A multicenter, randomized, double-blind study to compare the effects of VI-0521, Phentermine, and Placebo on Ambulatory Blood pressure in Overweight or Obese subjects
(PRINCIPAL INVESTIGATOR, 2022)

A DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MULTIPLE DOSE STRENGTHS OF CIN-107 AS COMPARED TO PLACEBO AFTER 8 WEEKS OF TREATMENT IN PATIENTS WITH UNCONTROLLED HYPERTENSION RECEIVING 1 ANTIHYPERTENSIVE AGENT
(PRINCIPAL INVESTIGATOR, 2021)

THE EFFECT OF LY2409021 ON BLOOD PRESSURE AND PULSE RATE, AS ASSESSED BY AMBULATORY BLOOD PRESSURE MONITORING, IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
(PRINCIPAL INVESTIGATOR 2014)

PERINDOPRIL AMLODIPINE FOR THE TREATMENT OF HYPERTENSION (PATH): A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY EVALUATING THE EFFICACY AND SAFETY OF A FIXED DOSE COMBINATION OF PERINDOPRIL ARGININE PLUS AMLODIPINE BESYLATE VERSUS PERINDOPRIL ERBUMINE AND AMLODIPINE BESYLATE IN SUBJECTS WITH ESSENTIAL HYPERTENSION
(PRINCIPAL INVESTIGATOR 2012)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 8-WEEK STUDY TO EVALUATE THE SAFETY AND EFFICACY OF NEBIVOLOL AND VALSARTAN GIVEN AS A FEXED DOSE COMBINATION IN PATIENTS WITH STAGE 1 OR 2 HYPERTENTION
(PRINCIPAL INVESTIGATOR 2011)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF NEBIVOLOL IN YOUNGER PATIENTS (18 - 54 YEARS) WHO HAVE STAGE 1 OR 2 ESSENTIAL HYPERTENSION
(PRINCIPAL INVESTIGATOR 2011)

A RANDOMIZED, UNBLINDED, SINGLE RESEARCH SITE, COMPARATOR STUDY OF RAISINS VERSUS ALTERNATIVE SNACKS ON CARDIOVASCULAR RISK FACTORS IN GENERALLY HEALTHY SUBJECTS
(PRINCIPAL INVESTIGATOR 2011)

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE EFFECTS OF FIRST LINE TREATMENT WITH A FREE COMBINATION OF NEBIVOLOL AND LISINOPRIL COMPARED WITH PLACEBO AND THE MONOTHERAPY COMPONENTS ON BLOOD PRESSURE IN PATIENTS WITH STAGE 2 DIASTOLIC HYPERTENSION
(PRINCIPAL INVESTIGATOR 2010)

A RANDOMISED, DOUBLE-BLIND, DOUBLE DUMMY, ACTIVE CONTROLLED, PARALLEL GROUP, FORCED TITRATION STUDY TO COMPARE THE FIXED-DOSE COMBINATION OF TELMISARTAN 80 MG PLUS HYDROCHLOROTHIAZIDE 25 MG (T80/HCTZ25) VERSUS TELMISARTAN 80 MG (T80) MONOTHERAPY AS FIRST LINE THERAPY IN PATIENTS WITH GRADE 2 OR GRADE 3 HYPERTENSION (SBP>=160 MM/HG AND DBP >=100MM HG)
(PRINCIPAL INVESTIGATOR 2010)

A RANDOMISED, DOUBLE-BLIND, DOUBLE DUMMY, ACTIVE CONTROLLED, PARALLEL GROUP, FORCED TITRATION STUDY TO COMPARE THE FIXED-DOSE COMBINATION OF TELMISARTAN 80 MG PLUS HYDROCHLOROTHIAZIDE 25 MG (T80/HCTZ24) VERSUS TELMISARTAN 80 MG (T80) MONOTHERAPY AS FIRST LINE THERAPY IN PATIENTS WITH SEVERE HYPERTENSION
(PRINCIPAL INVESTIGATOR 2009)

A PHASE 3, DOUBLE-BLIND, RANDOMIZED, EFFICACY AND SAFETY STUDY COMPARING THE TAK-491 PLUS CHLORTHALIDONE FIXED-DOSE COMBINATION VS BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE IN SUBJECTS WITH MODERATE TO SEVERE ESSENTIAL HYPERTENSION
(PRINCIPAL INVESTIGATOR 2009)

A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP, FACTORIAL DESIGN TRIAL TO ASSESS THE EFFICACY AND SAFETY OF UP TO SIX WEEKS TREATMENT WITH 20 MG, 40 MG, OR 80 MG QD DOSES CARVEDILOL CONTROLLED RELEASE FORMULATION (COREG CR) OR 10 MG, 20 MG, OR 40 MG QD DOSES OF LISINOPRIL (ZESTRIL) OR A COMBINATION OF ONE OF THE DOSES OF EACH MEDICATION
(PRINCIPAL INVESTIGATOR 2006)

A DOUBLE-BLIND, RANDOMIZED, MULTICENTER STUDY TO EVALUATE THE EFFECTIVENESS OF THE COMBINATION OF VALSARTAN AND AMLODIPINE IN HYPERTENSIVE PATIENTS NOT CONTROLLED ON MONOTHERAPY.
(PRINCIPAL INVESTIGATOR 2006)

A DOUBLE-BLIND, RANDOMIZED, PARALLEL, EFFICACY STUDY WITH LOSARTAN POTASSIUM ALONE OR IN COMBINATION WITH HYDROCHLOROTHIAZIDE VERSUS PLACEBO IN OBESE PATIENTS WITH ELEVATED SYSTOLIC AND DIASTOLIC BLOOD PRESSURE
(PRINCIPAL INVESTIGATOR 2006)

A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, 4X4 FACTORIAL DESIGN TRIAL TO EVALUATE TELMISARTAN 20, 40, AND 80 MG TABLETS IN COMBINATION WITH AMLODIPINE 2.5, 5, AND 10MG CAPSULES AFTER EIGHT WEEKS OF TREATMENT IN PATIENTS WITH STAGE I OR II HYPERTENSION, WITH AN ABPM SUB-STUDY.
(PRINCIPAL INVESTIGATOR 2005)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FORCED-TITRATION, PHASE IV STUDY COMPARING TELMISARTAN 80 MG + HYDROCHLOROTHIAZIDE 25 MG VERSUS VALSARTAN 160 MG + HYDROCHLOROTHIAZIDE 25 MG TAKEN ORALLY FOR EIGHT WEEKS IN PATIENTS WITH STAGE 1 OR STAGE 2 HYPERTENSION
(PRINCIPAL INVESTIGATOR 2005)

EFFECT OF ALAGEBRIUM (ALT-711) IN COMBINATION WITH FIXED-DOSE HYDROCHLOROTHIAZIDE THERAPY ON SYSTOLIC BLOOD PRESSURE IN HYPERTENSIVE PATIENTS
(PRINCIPAL INVESTIGATOR 2004)

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-FILTER STUDY TO EVALUATE THE ANTIHYPERTENSIVE EFFICACY AND SAFETY OF LOSARTAN-HCTZ COMBINATION AS COMPARED TO LOSARTAN MONOTHERAPY IN PATIENTS WITH ESSENTIAL HYPERTENSION
(PRINCIPAL INVESTIGATOR 2004)

A PHASE III, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP FACTORIAL STUDY OF METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS (TOPROL-XL), HYDROCHLOROTHIAZIDE AND THEIR COMBINATION PATIENTS WITH ESSENTIAL HYPERTENSION.
(PRINCIPAL INVESTIGATOR 2003 - 2004)

THE EFFICACY AND SAFETY OF AVALIDE 150/12.5 MG AND AVALIDE 300/25 MG IN PATIENTS WITH HYPERTENSION UNCONTROLLED ON MONOTHERAPY.
(PRINCIPAL INVESTIGATOR 2003 - 2004)

A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, FORCED-TITRATION, COMPARISON OF MICARDIS HCT (TELEMISARTAN 80 MG / HYDROCHLOROTHIAZIDE 25MG) VERSUS DIOVAN HCT (VALSARTAN 160MG / HYDROCHLOROTHIAZIDE 25 MG) USING SEATED TROUGH CUFF BLOOD PRESSURE IN PATIENTS WITH STAGE 1 AND STAGE 2 HYPERTENSION
(PRINCIPAL INVESTIGATOR 2003 - 2004)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CROSSOVER STUDY TO EVALUATE THE EFFECTS OF CELECOXIB 200 MG QD, CELECOXIB 200 MG BID, AND PLACEBO IN PATIENTS WITH TREATED HYPERTENSION
(PRINCIPAL INVESTIGATOR 2001)

DOUBLE -BLIND, RANDOMIZED, PARALLEL GROUP COMPARISON STUDY OF THE SAFETY OF CELECOXIB VS ROFECOXIB IN TREATED HYPERTENSIVE PATIENTS WITH OSTEOARTHRITIS (SUCCESS VII)
(PRINCIPAL INVESTIGATOR, 2000 - 2001)

OMAPATRILAT IN PERSONS WITH ENHANCED RISK OF ATHEROSCLEROTIC EVENTS: THE "OPERA" STUDY
(PRINCIPAL INVESTIGATOR, 2000 - 2001)

OMAPATRILAT CARDIOVASCULAR TREATMENT ASSESSMENT VERSUS ENALAPRIL (OCTAVE)
(PRINCIPAL INVESTIGATOR, 2000 - 2001)

OMAPATRILAT CARDIOVASCULAR TREATMENT ASSESSMENT VERSUS ENALAPRIL (OCTAVE) - PROSPECTIVE NESTED CASE-CONTROLLED STUDY OF POTENTIAL RISK FACTORS FOR ANGIOEDEMA IN SUBJECTS EXPOSED TO OMAPATRILAT OR ENALAPRIL
(PRINCIPAL INVESTIGATOR, 2000- 2001)

A RANDOMIZED, DOUBLE-BLIND SAFETY AND EFFICACY STUDY OF LOSARTAN PLUS HYDROCHLOROTHIAZIDE VERSUS LOSARTAN AS FIRST-LINE THERAPY AFTER 6 WEEKS IN PATIENTS WITH SEVERE HYPERTENSION
(PRINCIPAL INVESTIGATOR, 2000 - 2001)

A RANDOMIZED, DOUBLE-BLIND, AMLODIPINE- AND LOSARTAN-CONTROLLED STUDY OF OMAPATRILAT IN SUBJECTS WITH MILD TO MODERATE HYPERTENSION
(PRINCIPAL INVESTIGATOR, 1999 - 1999)

A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, INPATIENT STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND ANTIHYPERTENSIVE EFFICACY OF A MULTIPLE-DOSE REGIMEN OF L-7537,037 IN AFRICAN AMERICAN PATIENTS WITH MILD-TO-MODERATE HYPERTENSION
(PRINCIPAL INVESTIGATOR, 1998 - 1999)

THE EFFICACY AND SAFETY OF OMAPATRILAT ADDED TO HYDROCHLOROTHIAZIDE FOR THE TREATMENT OF HYPERTENSION IN SUBJECTS NON-RESPONSIVE TO HYDROCHLOROTHIAZIDE ALONE
(PRINCIPAL INVESTIGATOR, 1998 - 1999)

AN EVALUATION OF THE SAFETY AND EFFECTIVENESS OF AVAPRO FOR THE TREATMENT OF HYPERTENSION: A POST MARKETING SURVEILLANCE STUDY
(PRINCIPAL INVESTIGATOR, 1998)

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP COMPARATIVE TRIAL OF THE ANTIHYPERTENSIVE ACTIVITY AND SAFETY OF IRBESARTAN AND LOSARTAN IN SUBJECTS WITH MILD-TO-MODERATE HYPERTENSION
(PRINCIPAL INVESTIGATOR, 1996 - 1997)

RANDOMIZED, DOUBLE-BLIND PARALLEL TRIAL COMPARING LOTREL AT DIFFERING DOSES COMPARED TO NIFEDIPINE GITS IN PATIENTS WITH ESSENTIAL HYPERTENSION INADEQUATELY CONTROLLED WITH NIFEDIPINE ALONE, FOLLOWED BY A SINGLE-BLIND EXTENSION OF LOTREL 5/20 MG ONCE DAILY
(PRINCIPAL INVESTIGATOR, 1996 - 1997)

A MULTIPLE DOSE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTIFACTORIAL, PARALLEL TRIAL COMPARING THE COMBINATION THERAPY OF VALSARTAN (80MG OR 160 MG) AND HYDROCHLOROTHIAZIDE (12.5 MG OR 25 MG) TO VALSARTAN MONOTHERAPY (80 MG OR 160 MG), HYDROCHLOROTHIAZIDE MONOTHERAPY (12.5 MG OR 25 MG) AND PLACEBO IN HYPERTENSIVE PATIENTS AGE 18 - 80 YEARS
(PRINCIPAL INVESTIGATOR, 1995-1996)

FACTORIAL TRIAL OF THE EFFICACY AND SAFETY OF MULTIPLE DOSAGES OF IRBESARTAN AND HCTZ IN MILD TO MODERATE HYPERTENSION "MATRIX STUDY"
(PRINCIPAL INVESTIGATOR 1994-1996)

RESEARCH COMPLETED TRIALS THE EFFICACY AND SAFETY OF IRBESARTAN ADDED TO HYDROCHLOROTHIAZIDE FOR THE TREATMENT OF HYPERTENSION IN SUBJECTS NONRESPONSIVE TO HYDROCHLOROTHIAZIDE ALONE - "FILTER STUDY"
(PRINCIPAL INVESTIGATOR 1994-1996)

12 WEEK, OPEN-LABEL EVALUATION OF CATAPRES-TTS IN AFRICAN AMERICAN AND HISPANIC PATIENTS
(PRINCIPAL INVESTIGATOR 1994)

S.E.L.E.C.T. (SELECOR'S EFFECT LOWERING BP IN THOSE WITH ELEVATED CHOLESTEROL/TRIGLYCERIDES) STUDY
(PRINCIPAL INVESTIGATOR 1991)

Miscellaneous

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CROSSOVER, PHASE 2 STUDY EVALUATING THE SAFETY AND EFFICACY OF HORMONE REPLACEMENT THERAPY WITH ST-1891 COMPARED TO LEVOTHYROXINE IN PATIENTS WITH PRIMARY
HYPOTHYROIDISM
(PRINCIPAL INVESTIGATOR, 2022)

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOSE-CONVERSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF HORMONE REPLACEMENT THERAPY WITH ARMOUR® THYROID COMPARED TO SYNTHETIC T4 (LEVOTHYROXINE) IN PREVIOUSLY HYPOTHYROID PARTICIPANTS, WHO ARE EUTHYROID ON T4 REPLACEMENT THERAPY
(PRINCIPAL INVESTIGATOR 2019)

PROCUREMENT OF MATCHED PAIRS OF VENIPUNCTURE AND CAPILLARY BLOOD SPECIMENS FOR CORRELATION STUDIES PROTOCOL 13/1108
(PRINCIPAL INVESTIGATOR, 2019)

AN INTERNATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, ACTIVE (TOLTERODINE)-CONTROLLED MULTICENTER EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF VIBEGRON IN PATIENTS WITH SYMPTOMS OF OVERACTIVE BLADDER (RVT-901-3004)
(PRINCIPAL INVESTIGATOR, 2018)

AN INTERNATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, ACTIVE (TOLTERODINE)-CONTROLLED MULTICENTER EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VIBEGRON IN PATIENTS WITH SYMPTOMS OF OVERACTIVE BLADDER (RVT-901-3003)
(PRINCIPAL INVESTIGATOR, 2018)

ISPECIMEN NETWORK: RESEARCH USE ONLY COLLECTION AND DISTRIBUTION OF HUMAN BIOSPECIMENS FOR NOVEL RESEARCH USES
(PRINCIPAL INVESTIGATOR, 2017)

A CROSS-SECTIONAL METHOD COMPARISON STUDY OF THE FASTPACK 2.0 VITAMIN D WHOLE BLOOD IMMUNOASSAY SYSTEM TO LC-MS/MS MEASUREMENTS IN PAIRED SAMPLES
(PRINCIPAL INVESTIGATOR, 2017)

PRECISION OF THE AFINION HBA1C DX TEST IN FINGERSTICK SAMPLES (DEFT)
(PRINCIPAL INVESTIGATOR, 2017)

CLINICAL EVALUATION OF THE ACCURACY OF THE AFINION LIPID PANEL TEST IN A POINT OF CARE SETTING.
(PRINCIPAL INVESTIGATOR, 2016)

CLINICAL EVALUATION OF THE WHOLE BLOOD AND SERUM PRECISION OF THE AFINION LIPID PANEL.
(PRINCIPAL INVESTIGATOR, 2016)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EVENT-DRIVEN TRIAL OF WEEKLY LOW-DOSE METHOTREXATE (LDM) IN THE PREVENTION OF CARDIOVASCULAR EVENTS AMONG STABLE CORONARY ARTERY DISEASE PATIENTS WITH TYPE 2 DIABETES OR METABOLIC SYNDROME.
(PRINCIPAL INVESTIGATOR, 2016)

USABILITY AND HBA1C METHOD COMPARISON STUDY USING LAY-PERSON MICRO-BLOOD SPECIMENS
(PRINCIPAL INVESTIGATOR, 2015)

PROCUREMENT OF MATCHED PAIRS OF VENIPUNCTURE AND CAPILLARY BLOOD SPECIMENS FOR CORRELATION STUDIES. (PRINCIPAL INVESTIGATOR, 2015)

CLINICAL EVALUATION OF THE WHOLE BLOOD AND SERUM PRECISION OF THE AFINION LIPID PANEL (ABROAD)
(PRINCIPAL INVESTIGATOR 2012)

CLINICAL EVALUATION OF THE ACCURACY OF THE AFINION LIPID PANEL TEST IN A POINT OF CARE SETTING (ACTION)
(PRINCIPAL INVESTIGATOR 2012)

A 52 WEEK EXTENSION TO: A PHASE IIB, RANDOMIZED, PLACEBO AND ACTIVE COMPARATOR (TOLTERODINE) CONTROLLED, 2 - PART CLINICAL STUDY OF THE EFFICACY AND SAFETY OF MK-4618 IN PATIENTS WITH OVERACTIVE BLADDER
(PRINCIPAL INVESTIGATOR 2012)

A PHASE IIB, RANDOMIZED, PLACEBO AND ACTIVE COMPARATOR (TOLTERODINE) CONTROLLED, 2 - PART CLINICAL STUDY OF THE EFFICACY AND SAFETY OF MK-4618 IN PATIENTS WITH OVERACTIVE BLADDER
(PRINCIPAL INVESTIGATOR 2011)

EVALUATION OF CAPSULE ENDOSCOPY WITH PILLCAM COLON 2 IN VISUALIZATION OF THE COLON
(2011)

THE ADD-CKD STUDY: AWARENESS, DETECTION, AND DRUG THERAPY IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE
(PRINCIPAL INVESTIGATOR 2011)

A 6-MONTH, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE INCIDENCE OF GASTRIC ULCERS FOLLOWING ADMINISTRATION OF EITHER PA32540 OR ENTERIC COATED ASPIRIN 325 MG IN SUBJECTS WHO ARE AT RISK FOR DEVELOPING ASPIRIN-ASSOCIATED ULCERS
(PRINCIPAL INVESTIGATOR 2010)

A PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF ZOSTAVAX IN SUBJECTS 50-59 YEARS OF AGE
(PRINCIPAL INVESTIGATOR 2010)

A MULTI-CENTER, LONG-TERM, OPEN-LABEL EXTENSION STUDY OF [S,S]-REBOETINE (PNU-165442G) ADMINISTERED ONCE DAILY IN PATIENTS WITH FIBROMYALGIAS
(PRINCIPAL INVESTIGATOR 2008)

A PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, IMMUNOGENICITY, SAFETY AND TOLERABILITY OF ZOSTAVAX IN SUBJECTS 50 - 59 YEARS OF AGE
(PRINCIPAL INVESTIGATOR 2008)

A 14-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY OF [S,S]-REBOXETINE (PNU-165442G) ADMINISTERED ONCE DAILY (QD) IN PATIENTS WITH FIBROMYALGIA
(PRINCIPAL INVESTIGATOR 2008)

A RANDOMIZED-WITHDRAWAL PHASE III STUDY EVALUATING THE SAFETY AND EFFICACY OF CG5503 EXTENDED-RELEASE (ER) IN SUBJECTS WITH PAINFUL DIABETIC PERIPHERAL NEUROPATHY (DPN)
(PRINCIPAL INVESTIGATOR, 2007)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3, THREE ARM STUDY OF THE SAFETY AND EFFICACY OF PIRFENIDONE IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS
(PRINCIPAL INVESTIGATOR 2006)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER PHASE 3 STUDY TO EVAUATE THE LONG-TERM SAFETY OF ALVIMOPAN 0.5 MG TWICE DAILY FOR 12 MONTHS FOR THE TREATMENT OF OPIOID-INDUCED BOWEL DYSFUNCTION IN ADULTS TAKING OPIOID THERAPY FOR PERSISTENT NON-CANCER PAIN.
(PRINCIPAL INVESTIGATOR, 2005)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY ALVIMOPAN 0.5MG ONCE DAILY AND 0.5MG TWICE DAILY FOR 12 WEEKS FOR THE TREATMENT OF OPIOID-INDUCED BOWEL DYSFUNCTION IN ADULTS TAKING OPIOID THERAPY FOR PERSISTENT NON-CANCER PAIN
(PRINCIPAL INVESTIGATOR, 2005)

RANDOMIZED, DOUBLE-BLIND, PLACEBO AND ACTIVE-CONTROLLED, PARALLEL, MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF 3 ½ DAY COMBINATIONS OF 17B-ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL DELIVERY SYSTEMS FOR RELIEF OF MENOPAUSAL VASOMOTOR SYMPTOMS AND REDUCTION OF ENDOMETRIAL HYPERPLASIA
(PRINCIPAL INVESTIGATOR, 1997 - 2000)

A DOUBLE-BLIND, PARALLEL, PLACEBO CONTROLLED, MULTICENTER, POLYSOMOGRAPHIC STUDY OF THE EFFECTS OF L-759274 AND ZOLPIDEM IN PATIENTS WITH CHRONIC INSOMNIA
(SUBINVESTIGATOR, 1999 - 1999)