Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)
Completed · Phase 3
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT00386061
- Run by
- Sanofi
- People needed
- 1507
- Starts
- 2001-10-01
- Expected to finish
- 2004-06-01
- Last updated by the study team
- 2009-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- body mass index (BMI) e30 kg/m2 in patients with or without comorbidities, or BMI >27 kg/m2 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia.
- stable body weight (variation <5 kg within 3 months prior to screening visit);
You may not qualify if…
- History of very low-calorie diet within 6 months prior to screening visit; or history of surgical procedures for body weight loss (eg, stomach stapling, bypass);
- Presence of any clinically significant psychiatric , neurological or endocrine disease
- Presence of treated or untreated type 1 or type 2 diabetes);
- SBP >165 mmHg and/or DBP >105 mmHg on 2 consecutive visits from the screening to the inclusion visit;
- History of myocardial infarction or unstable angina pectoris within 6 months prior to screening visit; and history of stroke within 6 months prior to screening visit;
- Administration of anti-obesity drugs or other drugs for body weight reduction within 3 months prior to screening visit;
- The investigator will evaluate whether there are other reasons why a patient may not participate.
Where it is running
- Sanofi-Aventis — Bridgewater, New Jersey, United States
- Sanofi-Aventis — Brussels, Belgium
- Sanofi-Aventis — Helsinki, Finland
- Sanofi-Aventis — Paris, France
- Sanofi-Aventis — Berlin, Germany
- Sanofi-Aventis — Gouda, Netherlands
- Sanofi-Aventis — Bromma, Sweden
Full record on ClinicalTrials.gov
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