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
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
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014