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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 10, 2006

Last Updated Date

April 17, 2009

Start Date ^ICMJE

October 2001

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

change in body weight from baseline to 1 year.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00386061 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Drug: rimonabant (SR141716)

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1507

Completion Date

June 2004

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00386061

Other Study ID Numbers ^ICMJE

EFC4733

Has Data Monitoring Committee

Not Provided

Responsible Party

ICD Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi

Information Provided By

Sanofi

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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