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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
Information provided by:

October 10, 2006
October 11, 2006
April 20, 2009
October 2001
June 2004   (Final data collection date for primary outcome measure)
change in body weight from baseline to 1 year.
Same as current
Complete list of historical versions of study NCT00386061 on ClinicalTrials.gov Archive Site
HDL-C and TG from baseline to 1 year; ·patients (%) with improvement of glucose tolerance, patients (%) with NCEP-ATPIII metabolic syndrome at 1 year.
Same as current
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Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)
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)

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.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Drug: rimonabant (SR141716)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2004
June 2004   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Finland,   France,   Germany,   Netherlands,   Sweden,   United States
Not Provided
Not Provided
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ICD Study Director, sanofi-aventis
Not Provided
Study Director: ICD CSD Sanofi
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP