|
 |
Hypercholesterolemia
2011 - PI – Leslie Klaff, MD, Ph.D (Phase III)
A Randomized, Double-Blind, Active-Controlled, Multicenter, Crossover Study to Evaluate the Efficacy and Safety of A Fixed-Dose Combination Tablet Compared to Co-administration of Marketed Ezetimibe 10 mg and Atorvastatin 20 mg in Patients with Primary Hypercholesterolemia
2011 – PI – Ronald Brazg, MD (Phase II)
A Randomized, Placebo and Ezetimibe Controlled, Dose-Ranging Study to Evaluate Tolerability and Efficacy of An Investigational Subcutaneously Injected Medication on LDL-C in Hypercholesterolemic Subjects with a 10 year Framingham Risk Score of 10% or Less
2009 PI – Allen Sussman, MD
A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of an Investigational Extended-Release oral medication in Patients with Dyslipidemia
2008 PI - Allen Sussman, MD (Phase III)
A Multicenter, Randomized, Double-Blind, Titration Study to Evaluate 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
2008 PI - Allen Sussman, MD (Phase IIa)
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy and Tolerability of an investigational medication Co-Administered with Atorvastatin in Patients with Primary Hypercholesterolemia
2008 PI - Leslie Klaff, MD, Ph D (Phase III)
A Multicenter, Double-Blind, Randomized, 12-Month, Placebo-Controlled Study to Evaluate the Lipid-Lowering Effect, Safety, and Tolerability of an investigational medication 25mg/Day and 50mg/Day When Added to Ongoing Stable Statin Therapy (HMG-CoA reductase inhibitors) in Patients With Primary Hypercholesterolemia
2008 PI - Ronald Brazg, MD (Phase III)
A Multicenter, Randomized, Placebo-Controlled, "factorial"design, 12-Month Study to Evaluate the Efficacy and Safety of an investigational medication 25mg/Day and 50mg/Day co-administered with all registered Atorvatatin Stengths Ranging from 10mg to 80mg in Patients with Primary Hypercholesterolemia
2007 PI – Ronald Brazg, MD (Phase II)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of the Combination of an Investigational Medication and Atorvastatin 20mg vs. Monotherapy in Subjects With Moderate Hypercholesterolemia.
2007 PI – Ronald Brazg, MD (Phase III)
A Multicenter, Prospective, Longitudinal, Randomized, Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of Daily Administration of Pravastatin 40mg or Fenofibrate 160 mg or An Investigational Combination Medication for 12 Weeks Followed by a 52-Week Open Label Safety Phase of the Investigational Combination Medication Alone in the Treatment of Combined Hyperlipidemia.
2007 PI – Allen Sussman, MD (Phase III)
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.
2006 PI – Leslie Klaff, MD, PhD (Phase III)
A Multicenter, Randomized, Double-Blinded, Prospective Study Comparing the Safety and Efficacy of An Investigational Combination Therapy to Fenofibric Acid and Simvastatin Monotherapy in subjects with Mixed Dyslipidemia
2006 - PI – Leslie Klaff, MD, PhD (Phase III)
A Multicenter, Randomized, Double-Blinded, Prospective Study Comparing the Safety and Efficacy of An Investigational Combination Therapy to Fenofibric Acid and Atorvastatin Calcium Monotherapy in subjects with Mixed Dyslipidemia
2006- PI – Allen Sussman, MD (Phase IIb)
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Does-Ranging Study to Assess the Efficacy, Safety, and Tolerability of An Investigational Medication in Patients with Primary Hypercholesterolemia or Mixed Hyperlipidemia
2006 – PI – Leslie Klaff, MD, PhD (Phase III)
A Phase 3, Open-Label, Multi-Center, Randomized, Parallel Group Study of The Efficacy and Safety of Fixed Combination Investigational Medication/Atorvastatin Administered Once Daily (QD) Compated to Fixed Combination Ezetimibe/Simvastatin for 6 Week In Subjects with Dyslipidemia
2006 –PI – Allen Sussman (Phase III)
A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Lipid-Altering Efficacy, Safety and Tolerability of An Investigational Medication in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
2005 – PI – Leslie Klaff, MD, Ph.D (Phase III)
A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of An Investigational Medication When Co-Administered With Atorvastatin (10mg to 40mg) In Subjects With Primary Hypercholesterolemia
2005 – PI – Ronald Brazg, MD (Phase III)
Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of An Investigational Medication, for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Intima-Media Thickness (CIMT), in Overweight Patients With Additional Risk Factors
2005 – PI – Ronald Brazg, MD (Phase III)
A Multicenter, Randomized, Double-Blind, Parallel-Group, 6-Week Study to Evaluate the Efficacy and Safety an Investigational Medication Combination Tablet Versus Atorvastatin in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypercholesterolemia
2005 – PI – Allen Sussman, MD (Phase IIa)
A Multicenter, Randomized, Double-Blind, Parallel-Design Study to Evaluate the Lipid-Altering Efficacy of 2 Formulations of an investigational medication Compared to NIASPAN
2004 –PI – Allen Sussman, MD (Phase III)
A Study to Evaluate the Efficacy and Safety of an investigational medication Coadministration in Patients With Mixed Hyperlipidemia
2004 – PI – Leslie Klaff, MD, Ph.D (Phase III)
A Phase 3, double-blind, placebo-controlled, randomized, parallel group, multicenter study of the efficacy, safety and tolerability of an investigational medication administered orally, once daily for 24 weeks, compared to atorvastatin alone or placebo, in subjects with Frederickson Type IIa dyslipidemia.
2004 – PI – Allen Sussman, MD (Phase IIb)
Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of an investigational medication Compared to Placebo. Part B: A Dose-Ranging Study to Evaluate the Tolerability of an investigational medication and its Effects on Niacin-Induced Flushing in Lipid Clinic Patients.
2004 – PI – Ronald Brazg, MD (Phase 3)
A Multicenter, Randomized, Double-Blind Study to Evaluate the Lipid-Altering Efficacy and Safety of an investigational medication Versus Rosuvastatin in Patients With Primary Hypercholesterolemia.
2003 – Leslie Klaff, MD, Ph.D. (Phase 3)
Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-Mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination Investigational medication, Administered Orally, Once Daily (QD) for 24 Months, Compared with Atorvastatin Alone, in Subjects with Mixed Hyperlipidemia
2003 – PI – Leslie Klaff, MD, Ph.D.. (Phase 4)
A Multicenter, Double-Blind, Randomized, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of An Investigational Medication Tablet Versus Atorvastatin in Patients With Hypercholesterolemia.
2002 – PI – Allen Sussman, MD (Phase 2)
An 8-Week, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of an investigational medication Administered in Combination With Atorvastatin or Alone to Hypercholesterolemic Patients
2002 – (PI – Ronald Brazg, MD (Phase II)
Phase 2 multi-center, double-blind investigational medication, placebo-controlled, randomized, parallel group, dose ranging study of the efficacy, safety, tolerability, and pharmacokinetics of the investigational medication and open-label atorvastatin when concurrently administered orally twice daily (BID) for 12 weeks to subjects with elevated low-density lipoprotein cholesterol and without overt cardiovascular disease
2002 –PI – Ronald Brazg, MD (Phase II)
Phase 2 multi-center, double-blind investigational medication, placebo-controlled, randomized, parallel group, dose ranging study of the efficacy, safety, tolerability, and pharmacokinetics of an investigational medication 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
2002 PI - Leslie Klaff MD, PhD.
A multicenter, randomized, double-blind, placebo-and-active-controlled parallel group dose-ranging study of an investigational medication in the treatment of hyperlipidemia.
2002 PI - Ronald Brazg, MD
A Randomized, double - blind, parallel, multicenter study to evaluate the efficacy and safety of Simvastatin monotherapy compared with simvastatin plus an investigational medication in Type 2 Diabetic patients treated with Thiazolidinediones.
2002 PI - Allen Sussman, MD
A comparison of treatment with an investigational medication and Simvastatin coadministration versus Simvastatin in attaining the National Cholesterol Educational Program (NCEP) Adult Treatment Panel (ATP) III coronary heart disease (CHD) or CHD risk equivalent strata low-density lipoprotein cholesterol (LDL-C) Target Level.
2002 PI - Ronald Brazg, MD
A multicenter, double-blind, randomized, placebo- and active-controlled, parallel study to evaluate the lipid altering efficacy and safety of an investigational medication in patients with metabolic syndrome and dyslipidemia.
2002 PI - Ronald Brazg, MD
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 an investigational medication administered once a day for 8 weeks to subjects with moderate elevations in low-density lipoprotein cholesterol levels and without overt cardiovascular disease.
2001 PI - Ronald Brazg, MD
A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group, Study of the Safety and Efficacy of Cerivastatin in Combination with Fenofibrate Alone and Placebo in a Population of Type 2 Diabetic Men and Women
2001 PI - Leslie Klaff, MD, Ph.D.
A 6-week, Open-Label, Dose-Comparison Study to Evaluate Statins in Subjects With Hypercholesterolemia
2000 - PI Allen Sussman, MD
A Randomized, Double-Blind, Placebo-Controlled, Parallel, Multicenter Study to Evaluate the Efficacy and Safety of Treatment With A Lipid-Lowering Medication In Thiazolidinedione-Treated (Pioglitazone or Rosiglitazone) Type 2 Diabetic Patients
2000 PI - Leslie Klaff, MD, Ph.D.
A Double-Blind Comparison of An Investigational Medication with Placebo in Hypercholesterolemic Subjects
2000 PI - Ronald Brazg, MD
An Open-Label Randomized Study of the Relative Efficacy of An Investigational Medication compared to Simvastatin and Atorvastatin
2000 PI - Ronald Brazg, MD
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Forced-Titration Study of the Safety and Effectiveness of An Investigational Medication vs. Placebo in Japanese-American and Caucasian-American Patients With Hypercholesterolemia
1999 PI - Leslie J. Klaff, MD, Ph.D.
A 12-week Randomized Double-blind Placebo-controlled Multicenter Trial to Evaluate the Efficacy and Safety of ZD4522 (5 and 10mg) and Atorvastatin (10mg) in the treatment of Subjects with Hypercholesterolemia.
1999 PI - Ronald L. Brazg, MD
Evaluation of the Safety and Efficacy of Nicostatin (a combination tablet of niacin extended-release/lovastatin immediate release): A Dose Ranging Study
1998 PI - Leslie J. Klaff, MD, Ph.D.
An Open-Label, Community-Based Clinical Practice Study of Niaspan in Patients with Hyperlipidemia
1997 PI - Ronald L. Brazg, MD
A Randomized, Double-Blind, Parallel Group Evaluation of an Investigational Medication 0.8 mg Compared to an Investigational Medication 0.4 mg and Placebo/Pravastatin 20 mg Once Daily in Patients with Hypercholesterolemia
1996 PI - Leslie Klaff, MD, Ph.D.
A Randomized, Double-blind, Parallel Group Evaluation of an Investigational Medication compared to Fluvastatin 40 mg and Placebo Daily in Patients with Hypercholesterolemia
1995-1996 PI - Allen Sussman, MD
Third Long-Term Extension to: A Double-blind Dose-Ranging Study of an Investigational Medication Compared to Placebo and to Lovastatin taken once daily in Patients with Hypercholesterolemia.
1995 PI - Allen Sussman, MD
A Double-blind Dose-Ranging Study of an Investigational Medication Compared to Placebo and to Lovastatin taken Once Daily in Patients with Hypercholesterolemia.
1993-94 PI - Nancy L. Purcell, MD
A Double Blind Dose-Ranging Study of an Investigational Medication taken Once Daily Compared to Placebo and to Lovastatin taken Once Daily in Patients with Hypercholesterolemia
1991-1992 PI - Leslie J. Klaff, MD, Ph.D.
A Double-blind Pilot Dose Ranging Study of an investigational medication taken Once Daily Compared to Placebo and to Lovastatin taken Once Daily in Patients With Hypercholesterolemia |
Phase I & Pharmacokinetic Unit