Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00386061
First received: October 10, 2006
Last updated: April 17, 2009
Last verified: April 2009
  Purpose

The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities.

The main secondary objectives were to assess the effect of SR141716 on lipid parameters (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist circumference, glycemic parameters.


Condition Intervention Phase
Obesity
Drug: rimonabant (SR141716)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety of SR141716 in Obese Patients With or Without Comorbidities (RIO-Europe)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • change in body weight from baseline to 1 year.

Secondary Outcome Measures:
  • HDL-C and TG from baseline to 1 year; ·patients (%) with improvement of glucose tolerance, patients (%) with NCEP-ATPIII metabolic syndrome at 1 year.

Enrollment: 1507
Study Start Date: October 2001
Study Completion Date: June 2004
Primary Completion Date: June 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

Inclusion Criteria:

  • body mass index (BMI) e30 kg/m2 in patients with or without comorbidities, or BMI >27 kg/m2 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia.
  • stable body weight (variation <5 kg within 3 months prior to screening visit);

Exclusion Criteria:

  • History of very low-calorie diet within 6 months prior to screening visit; or history of surgical procedures for body weight loss (eg, stomach stapling, bypass);
  • Presence of any clinically significant psychiatric , neurological or endocrine disease
  • Presence of treated or untreated type 1 or type 2 diabetes);
  • SBP >165 mmHg and/or DBP >105 mmHg on 2 consecutive visits from the screening to the inclusion visit;
  • History of myocardial infarction or unstable angina pectoris within 6 months prior to screening visit; and history of stroke within 6 months prior to screening visit;
  • Administration of anti-obesity drugs or other drugs for body weight reduction within 3 months prior to screening visit;

The investigator will evaluate whether there are other reasons why a patient may not participate.

  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: NCT00386061

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Belgium
Sanofi-Aventis
Brussels, Belgium
Finland
Sanofi-Aventis
Helsinki, Finland
France
Sanofi-Aventis
Paris, France
Germany
Sanofi-Aventis
Berlin, Germany
Netherlands
Sanofi-Aventis
Gouda, Netherlands
Sweden
Sanofi-Aventis
Bromma, Sweden
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00386061     History of Changes
Other Study ID Numbers: EFC4733
Study First Received: October 10, 2006
Last Updated: April 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Obesity
risk factors

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014