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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2004

Interventions

  • Drug: rimonabant (SR141716)

Clinical Trial Outcome Measures

Primary Measures

  • change in body weight from baseline to 1 year.

Secondary 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • ICD Study Director, sanofi-aventis
  • Overall Official(s)
    • ICD CSD, Study Director, Sanofi

Citations Reporting on Results

Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rossner S; RIO-Europe Study Group. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005 Apr 16-22;365(9468):1389-97. doi: 10.1016/S0140-6736(05)66374-X. Erratum In: Lancet. 2005 Jul 30-Aug 5;366(9483):370.

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