Obese Patients With or Without Comorbidities (RIO-North America)

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: January 23, 2002
Last updated: April 17, 2009
Last verified: April 2009

January 23, 2002
April 17, 2009
August 2001
April 2004   (final data collection date for primary outcome measure)
Change in body weight
Not Provided
Complete list of historical versions of study NCT00029861 on ClinicalTrials.gov Archive Site
Metabolic parameters
Not Provided
Not Provided
Not Provided
Obese Patients With or Without Comorbidities (RIO-North America)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing and Prevention of Weight Regain Effects and Safety in Obese Patients With or Without Comorbidities
To assess the effects of weight loss and weight maintenance over a period of two years when prescribed with a hypocaloric diet in obese patients with or without comorbidities
Not Provided
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Obesity
  • Weight Loss
Drug: Rimonabant (SR141716)
Not Provided
Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J; RIO-North America Study Group. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA. 2006 Feb 15;295(7):761-75. Erratum in: JAMA. 2006 Mar 15;295(11):1252.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2004
April 2004   (final data collection date for primary outcome measure)
  • Stable weight (variation of less than 5 kg within 3 months prior to screening visit)
  • BMI (Body Mass Index) of 30 or greater in patients with or without comorbidities, or BMI greater than 27 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
Not Provided
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