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

Obesity Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386061
• Other study ID #: EFC4733
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2006
• Last updated: April 17, 2009
• Start date: October 2001
• Est. completion date: June 2004

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1507
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• rimonabant (SR141716)

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis	Brussels
Finland	Sanofi-Aventis	Helsinki
France	Sanofi-Aventis	Paris
Germany	Sanofi-Aventis	Berlin
Netherlands	Sanofi-Aventis	Gouda
Sweden	Sanofi-Aventis	Bromma
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  Finland,  France,  Germany,  Netherlands,  Sweden, 

References & Publications (1)

Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rössner 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 s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in body weight from baseline to 1 year.
Secondary	HDL-C and TG from baseline to 1 year; ·patients (%) with improvement of glucose tolerance, patients (%) with NCEP-ATPIII metabolic syndrome at 1 year.