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

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00029861

First received: January 23, 2002

Last updated: April 17, 2009

Last verified: April 2009

History of Changes

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 (SR141716)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Change in body weight

Secondary Outcome Measures:

Metabolic parameters

Enrollment:	3045
Study Start Date:	August 2001
Study Completion Date:	April 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

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

Investigators

Study Director:

ICD CSD

Sanofi

More Information

Publications:

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:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00029861 History of Changes
Other Study ID Numbers:	EFC4743
Study First Received:	January 23, 2002
Last Updated:	April 17, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi:

Weight Loss
Obesity
Weight Reduction
Overweight

Additional relevant MeSH terms:

Obesity
Weight Loss
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 22, 2013

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