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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Body Weight
Obesity
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014