Obese Patients With Untreated Dyslipidemias

Obesity Clinical Trial

— RIO-Lipids  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029835
• Other study ID #: EFC4735
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2002
• Last updated: April 17, 2009
• Start date: September 2001
• Est. completion date: November 2003

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1033
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

• 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)

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Obesity

Intervention

Drug:
• Rimonabant (SR141716)

Locations

Country	Name	City	State
Australia	Sanofi-aventis Administrative Office	Macquarie Park
Canada	Sanofi-aventis Administrative Office	Laval
Finland	Sanofi-aventis Administrative Office	Helsinki
Italy	Sanofi-aventis Administrative Office	Milano
Spain	Sanofi-aventis Administrative Office	Barcelona
Sweden	Sanofi-aventis Administrative Office	Bromma
Switzerland	Sanofi-aventis Administrative Office	Geneva
United States	New Mexico Clinical Research & Osteoporosis Center, Inc.	Albuquerque	New Mexico
United States	Twin Cities Clinical Research	Arden Hills	Minnesota
United States	Clinical Research Services	Bismarck	North Dakota
United States	Medical University of South Carolina, Division of Clinical Pharmacology	Charleston	South Carolina
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Radiant Research	Edina	Minnesota
United States	Clinical Research Center of Northern Virginia	Falls Church	Virginia
United States	Irvine Center for Clinical Research (ICCR)	Irvine	California
United States	Women's Clinic of Lincoln, PC	Lincoln	Nebraska
United States	Los Angeles Clinical Trials	Los Angeles	California
United States	Bluegrass Clinical Research, Inc.	Louisville	Kentucky
United States	Johns Hopkins Women's Research Core	Lutherville	Maryland
United States	Clinic of Physicians and Surgeons, LTD	Mesa	Arizona
United States	Addiction & Psychiatric Medicine Research	Morgantown	West Virginia
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Clinical Research Division	Newtown	Pennsylvania
United States	nTouch Research	Peoria	Illinois
United States	Hunter Holmes McGuire Medical Center Research Service (151)	Richmond	Virginia
United States	Radiant Research	Salt Lake City	Utah
United States	Apexute	Santa Ana	California
United States	nTouch Research	South Bend	Indiana
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Radiant Research	Stuart	Florida
United States	Arizona Clinical Research Center, Inc.	Tucson	Arizona
United States	Vancouver Medical Weight Loss Clinic	Vancouver	Washington
United States	Clinical Research Center of Reading, LLC	West Reading	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Finland,  Italy,  Spain,  Sweden,  Switzerland, 

References & Publications (1)

Després JP, Golay A, Sjöström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in body weight at 1 year.
Secondary	Metabolic parameters