NCT Number: NCT00386061
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Sanofi-Aventis, Brussels, Belgium
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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.
Treatment and study plan
Primary outcomes
-
change in body weight from baseline to 1 year.
Secondary outcomes
-
HDL-C and TG from baseline to 1 year; ·patients (%) with improvement of glucose tolerance, patients (%) with NCEP-ATPIII metabolic syndrome at 1 year.
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Lead sponsor
Sanofi
Industry
Registry information
Official study 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)
Important dates
- Study start
- 2001
- Primary completion
- 2004
- Study completion
- 2004
- First posted
- Oct 11, 2006
- Registry last updated
- Apr 20, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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