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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029861
• Other study ID #: EFC4743
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2002
• Last updated: April 17, 2009
• Start date: August 2001
• Est. completion date: April 2004

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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3045
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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

Study Design

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Drug:
• Rimonabant (SR141716)

Locations

Country	Name	City	State
Canada	Corunna Medical Clinic	Corunna	Ontario
Canada	Quarry Family Medicine Clinic	Kingston	Ontario
Canada	Trial Management Group	Richmond Hill	Ontario
Canada	Group North	Windsor	Ontario
United States	Lovelace Scientific Resources	Albuquerque	New Mexico
United States	Medical Dietetics, Inc.	Atlanta	Georgia
United States	Radiant Research	Austin	Texas
United States	Pennington Center	Baton Rouge	Louisiana
United States	South Dayton Research Associates	Beavercreek	Ohio
United States	Radiant Research	Birmingham	Alabama
United States	Center for Nutrition and Preventive Medicine	Charlotte	North Carolina
United States	ClinSearch	Chattanooga	Tennessee
United States	Lindner Clinical Trials Center	Cincinnati	Ohio
United States	Radiant Research	Columbus	Ohio
United States	East Bay Clinical Trial Center	Concord	California
United States	Dallas Diabetes and Endocrine Center	Dallas	Texas
United States	Endocrinology and Diabetes Consultants, PC	Dover	New Hampshire
United States	Ranch View Family Medicine	Highlands Ranch	Colorado
United States	nTouch Research	Houston	Texas
United States	Medical Research Consortium	Indianapolis	Indiana
United States	Radiant Research	Lawrenceville	New Jersey
United States	University of KY Internal Medicine	Lexington	Kentucky
United States	Longmont Medical Research Network	Longmont	Colorado
United States	Clinical Nutrition Clinic, University of Wisconsin	Madison	Wisconsin
United States	Central New York Clinical Research	Manlius	New York
United States	Miami Research Associates	Miami	Florida
United States	Montana Medical Research, LLC	Missoula	Montana
United States	Anchor Research Center	Naples	Florida
United States	Clinical Research Associates, Inc	Nashville	Tennessee
United States	Comprehensive Weight Control Program	New York	New York
United States	St. Luke's Roosevelt Hospital Center	New York	New York
United States	Health Core, Inc.	Newark	Delaware
United States	Central Florida Clinical Solutions	Ocoee	Florida
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Radiant Research	Phoenix	Arizona
United States	Radiant Research	Portland	Oregon
United States	Multi-Specialty Research Associates of North Carolina	Raleigh	North Carolina
United States	Rainer Clinical Research Center, Inc.	Renton	Washington
United States	Commonwealth Clinical Research Specialists (CCRS)	Richmond	Virginia
United States	Advanced Clinical Research	Salt Lake City	Utah
United States	Quality Research, Inc.	San Antonio	Texas
United States	Feighner Research Institute	San Diego	California
United States	Scripps Clinic	San Diego	California
United States	SFM Clinical Trials	Scotland	Pennsylvania
United States	Springfield Diabetes and Endocrine Center	Springfield	Illinois
United States	JM Clinical Trials, Inc.	Swansea	Massachusetts
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	George Washington Univ. Wieght Mmgt Program	Washington	District of Columbia
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Wichita Clinic, PA	Wichita	Kansas
United States	Radiant Research	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J; RIO-North America Study Group. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight
Secondary	Metabolic parameters