Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)
The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities.
The main secondary objectives were to assess the effect of SR141716 on lipid parameters (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist circumference, glycemic parameters.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety of SR141716 in Obese Patients With or Without Comorbidities (RIO-Europe)|
- change in body weight from baseline to 1 year.
- HDL-C and TG from baseline to 1 year; ·patients (%) with improvement of glucose tolerance, patients (%) with NCEP-ATPIII metabolic syndrome at 1 year.
|Study Start Date:||October 2001|
|Study Completion Date:||June 2004|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||ICD CSD||Sanofi|