Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)
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|ClinicalTrials.gov Identifier: NCT00386061|
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : April 20, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Drug: rimonabant (SR141716)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1507 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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)|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||June 2004|
|Actual Study Completion Date :||June 2004|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386061
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||ICD CSD||Sanofi|