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

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ClinicalTrials.gov Identifier: NCT00029861
Recruitment Status : Completed
First Posted : January 24, 2002
Last Update Posted : April 20, 2009
Sponsor:
Information provided by:
Sanofi

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Weight Loss Drug: Rimonabant (SR141716) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3045 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2001
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in body weight

Secondary Outcome Measures :
  1. Metabolic parameters


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00029861


  Show 51 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi

Publications of Results:
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00029861     History of Changes
Other Study ID Numbers: EFC4743
First Posted: January 24, 2002    Key Record Dates
Last Update Posted: April 20, 2009
Last Verified: April 2009

Keywords provided by Sanofi:
Weight Loss
Obesity
Weight Reduction
Overweight

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs