Obese Patients With Untreated Dyslipidemias - Full Text View

Obese Patients With Untreated Dyslipidemias (RIO-Lipids)

This study has been completed.

First Received on January 23, 2002. Last Updated on April 17, 2009 History of Changes

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00029835

Purpose

To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia

Condition	Intervention	Phase
Obesity Dyslipidemia	Drug: Rimonabant (SR141716)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multi-Center Study of Weight-Reducing Effect and Safety in Obese Patients With Untreated Dyslipidemias

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: SR 141716A Rimonabant

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change from baseline in body weight at 1 year.

Secondary Outcome Measures:

Metabolic parameters

Enrollment:	1033
Study Start Date:	September 2001
Study Completion Date:	November 2003
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

BMI must be greater than 27 and less than 40
Patients with untreated dyslipidemia
Stable weight (variation of less than 5 kg within 3 months prior to screening visit)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029835

Show 35 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Publications:

Despres JP, Golay A, Sjostrom L; Rimonabant in Obesity-Lipids Study Group. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med. 2005 Nov 17;353(20):2121-34.

Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00029835 History of Changes
Other Study ID Numbers:	EFC4735
Study First Received:	January 23, 2002
Last Updated:	April 17, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Obesity

Additional relevant MeSH terms:

Obesity
Dyslipidemias
Overnutrition
Nutrition Disorders
Overweight

Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on February 12, 2012