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

Purpose

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

Condition	Intervention	Phase
Obesity Weight Loss	Drug: Rimonabant	Phase III

Genetics Home Reference related topics:

Obesity

MedlinePlus related topics:

Obesity Weight Control

ChemIDplus related topics:

Rimonabant SR 141716A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change in body weight

Secondary Outcome Measures:

Metabolic parameters

Enrollment:	3045
Study Start Date:	August 2001
Study Completion Date:	April 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029861

Show 51 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	ICD CSD	Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC4743, SR141716
First Received:	January 23, 2002
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00029861
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Weight Loss

Obesity

Weight Reduction

Overweight

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Weight Loss

Body Weight Changes

Nutrition Disorders

Overnutrition

Overweight

ClinicalTrials.gov processed this record on July 08, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00029861