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Now offering:  Phase I & Pharmacokinetic Unit

Synopsis of Completed and Current Studies

Obesity / Weight Loss

2010 –PI - Ronald Brazg, MD (Phase 2b)

A Double Blind, Multi-Center, Randomized, Parallel-Group, Study to Assess the Efficacy and Safety 400 mg of An Investigational Medication and 120 mg of Orlistat Administered Individually or Combined Orally Three Times Per Day with a Reduced Calorie Diet (RCD) in Obese Subjects.

2009 –PI – Allen Sussman, MD (Phase 3a) – Study Awarded

Effect of An Investigational Medication on Body Weight in Non-Diabetic Obese Subjects or Overweight Subjects With Comorbidities: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicentre, Multinational Trial with Stratification of Subject to Either One or Three Years of Treatment Based on Pre-Diabetes Status at Randomization.

2008  PI – Leslie Klaff, MD, Ph D (Phase 2)     
The Effect of Dose Titration of an Investigational Medication in Overweight and Obese Patients with Type 2 Diabetes Mellitus

2008 PI - Ronald Brazg, MD (Phase 2)
A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Efficacy and Safety Trial to Evaluate the Effect of an investigational medication on Weight in Obese and Overweight Subjects

 
2007 PI - Allen Sussman, MD (Phase 3)
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Determine the Safety and Efficacy of An Investigational Medication in the Treatment of Obesity in An Adult Population with BMI>35
 
2007 PI - Allen Sussman, MD (Phase 3)
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Determine the Safety and Efficacy of An Investigational Medication in the Treatment of Obesity in Adults with Obesity-Related Co-Morbid Conditions
 
2007 PI - Ronald Brazg, MD (Phase 3)
A Double-Blind, Multi-Center, Randomized, Parallel-Group, Yearlong Study to Asssess the Efficacy and Safety of An Investigational Medication Administered Orally Once Daily with A Reduced Calorie Diet in Obese Males and Females.
 
2006- PI – Ronald Brazg, MD
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter study Evaluating the Efficacy and Safety of Three Doses of An Investigational Medication in Abdominally Obese Patients with Atherogenic Dylsipidemia.
 
2006 - PI – Leslie Klaff, MD, Ph.D (Phase III)
A 2-Year, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of An Investigational Medication in the Treatment of Obese Subjects.
 
2006 - PI – Leslie Klaff, MD, Ph.D (Phase III)
A 1-Year, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of An Investigational Medication in the Treatment of Overweight, Oral Agent-Treated Subjects with Type 2 Diabetes Mellitus.
 
2006 - PI – Ronald Brazg, MD (Phase 2)
Study to Assess the Efficacy and Tolerability of An Investigational Medication in Maintaining Weight Loss Induced by Diet in Obese Patients
 
2006 - PI – Leslie Klaff, MD, Ph.D. (Phase IV)
Effect on Weight Loss of An Approved Medication vs. Placebo in Subjects with Type 2 Diabetes Participating in a Lifestyle Modification Program.
 
2006 - PI – Ronald Brazg, MD (Phase IIa)
A Study to Assess the Safety, Tolerability, and Efficacy of An Investigational Medication in Obese Patients
 
2005- (Phase III) PI – Ronald Brazg, MD
Randomized, multicenter, double-blind, placebo-controlled, two-arm parallel group trail of rimonabant 20-mg od, for inhibitor of atherosclerosis progression assessed by carotid artery intima-media thickness (CIMT), in overweight patients with additional risk factors.
 
2005 –PI – Ronald Brazg, MD (Phase II)
A Double-Blind, Multicenter Randomized Parallel Group, 16-Week Study of An Investigational Medication Administered Orally Once A Day With or Without a Low Calorie Diet Lead –In Obese Males and Females
 
2005 – PI – Leslie Klaff, MD,Ph.D (Phase IIa)
A Dose Titration Study to Assess the Efficacy, Safety and Tolerability of An Investigational Medication in Obese Patients
 
2005 – PI – Allen Sussman, MD (Phase III)
A Two-Year Study (One Year Weight Loss followed by One Year Prevention of Weight Regain) to Assess the Safety, Tolerability and Efficacy of An Investigational Medication in Obese Patients
 
2005 – PI – Ronald Brazg, MD (Phase Ib)
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of An Investigational Nasal Spray in Obese Patients
 
2004 –PI – Ronald Brazg, MD (Phase IIa)
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of an investigational medication in Obese Patients
 
2004 – PI – Ronald Brazg, MD (Phase IIa)
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Assess the Efficacy and Safety of an investigational medication in the Treatment of Obese, Type 2 Diabetic Subjects Managed with Diet or Metformin.
 
2003 – PI – Ronald Brazg, MD (Phase III)
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of an investigational medication in Maintaining Weight Loss Induced by a Very Low Calorie Diet in Obese Patients
 
2003 – Ronald Brazg, MD (Phase III)
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of an investigational medication in Obese Patients
 
2002 –PI – Ronald Brazg, MD (Phase IIa)
A dose range-finding, double-blind, randomized, placebo-controlled, multicenter study to assess the safety, tolerability, and efficacy of an investigational medication in obese subjects.
 
2001 PI - Allen Sussman, MD
A randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, multicenter study of weight-reducing and prevention of weight regain effects and safety of an investigational drug in obese patients with or without comorbidities.
 
2001 PI - Ronald Brazg, MD
A Phase III, 12-month, double blind, randomized, parallel group, placebo controlled, efficacy and safety study of an investigational medication in overweight and obese subjects with a 12-month open-label extension phase.
 
2001 PI - Ronald Brazg, MD
A Phase III, Multicenter, Two-Arm Study to Assess the Efficacy and Safety of An Investigational Oral Medication in the Treatment of Obesity in Subjects With Hypertension and/or Dyslipidemia
 
2001 PI - Allen Sussman, MD
An Investigational Medication Dose-Response, Efficacy, and Safety: A 12-Week Randomized, Multicenter, Double-Blind, Double-Dummy, Parallel-Group Study of Metformin and Five Doses of an Investigational Medication in Previously Treated OHA Monotherapy Obese Subjects With Type 2 Diabetes
 
1999 PI - Ronald Brazg, MD
A Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Four Doses of an Investigational Medication in Obese Patients
 
1999 PI - Allen M. Sussman, MD
A Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Safety and Efficacy of Subcutaneously Administered A-300 in Obese Subjects.
 
1996 PI - Ronald Brazg, MD
A Fifty-Two Week, Multicenter, Double-blind, Placebo-Controlled, Parallel-Group Study to Compare the Effects of an Investigational Medication With Those of Placebo in Mild to Moderate Obese Patients Whose Hypertension is Controlled by a Calcium-Channel Blocker, With or Without Concomitant Thiazide Diuretic Therapy.
 
1992-1993 PI - Allen Sussman, MD
Evaluation of an investigational medication Versus Placebo for Gallstone Prophylaxis During Very Low Calorie Diet-Induced Rapid Weight Loss

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