Status:
COMPLETED
Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)
Lead Sponsor:
Sanofi
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 com...
Eligibility Criteria
Inclusion
- 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);
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
1507 Patients enrolled
Trial Details
Trial ID
NCT00386061
Start Date
October 1 2001
End Date
June 1 2004
Last Update
April 20 2009
Active Locations (7)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis
Brussels, Belgium
3
Sanofi-Aventis
Helsinki, Finland
4
Sanofi-Aventis
Paris, France