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

April 17, 2009 updated by: Sanofi

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1507

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Sanofi-Aventis
  • Finland
      • Helsinki, Finland
        • Sanofi-Aventis
  • France
      • Paris, France
        • Sanofi-Aventis
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis
  • Netherlands
      • Gouda, Netherlands
        • Sanofi-Aventis
  • Sweden
      • Bromma, Sweden
        • Sanofi-Aventis
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
change in body weight from baseline to 1 year.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

October 10, 2006

First Submitted That Met QC Criteria

October 10, 2006

First Posted (Estimate)

October 11, 2006

Study Record Updates

Last Update Posted (Estimate)

April 20, 2009

Last Update Submitted That Met QC Criteria

April 17, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC4733

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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