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

This study has been completed.

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00029861
  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
 
Related Info  This link exits the ClinicalTrials.gov site
 

Publications of Results:

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




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