Obese Patients With or Without Comorbidities (RIO-North America) - Tabular View

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Obese Patients With or Without Comorbidities (RIO-North America)

This study has been completed.
Information provided by Sanofi-Aventis

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Obese Patients With or Without Comorbidities (RIO-North America)

Official Title ^†

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing and Prevention of Weight Regain Effects and Safety in Obese Patients With or Without Comorbidities

Brief Summary

To assess the effects of weight loss and weight maintenance over a period of two years when prescribed with a hypocaloric diet in obese patients with or without comorbidities

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Change in body weight

Secondary Outcome Measure ^†

Metabolic parameters

Condition ^†

Obesity
Weight Loss

Intervention ^†

Drug: Rimonabant

MEDLINE PMIDs

16478899

Links

Related Info This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

3045

Start Date ^†

August 2001

Completion Date

April 2004

Eligibility Criteria ^†

Stable weight (variation of less than 5 kg within 3 months prior to screening visit)
BMI (Body Mass Index) of 30 or greater in patients with or without comorbidities, or BMI greater than 27 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Canada

Administrative Information Fields

NCT ID ^†

NCT00029861

Organization ID

EFC4743

Secondary IDs ^††

SR141716

Study Sponsor ^†

Sanofi-Aventis

Collaborators ^††

Investigators ^†

Study Director:

ICD CSD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

June 2008

First Received Date ^†

January 23, 2002

Last Updated Date

June 6, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.