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

Phase 3

Completed

• Conditions: Obesity

• Registration Number: NCT00386061
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-11
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-17
• Last Update Posted: 2009-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1507

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);

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in body weight from baseline to 1 year.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇸🇪 Bromma, Sweden