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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00029861

Purpose

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

Condition	Intervention	Phase
Obesity Weight Loss	Drug: Rimonabant (SR141716)	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: SR 141716A Rimonabant

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change in body weight

Secondary Outcome Measures:

Metabolic parameters

Enrollment:	3045
Study Start Date:	August 2001
Study Completion Date:	April 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029861

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Locations

United States, Alabama
Radiant Research
Birmingham, Alabama, United States, 35209
United States, Arizona
Radiant Research
Phoenix, Arizona, United States, 85013
United States, California
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
Feighner Research Institute
San Diego, California, United States, 92121
Scripps Clinic
San Diego, California, United States, 92130
East Bay Clinical Trial Center
Concord, California, United States, 94520
United States, Colorado
Longmont Medical Research Network
Longmont, Colorado, United States, 80501
Ranch View Family Medicine
Highlands Ranch, Colorado, United States, 80130
United States, Delaware
Health Core, Inc.
Newark, Delaware, United States, 19713
United States, District of Columbia
George Washington Univ. Wieght Mmgt Program
Washington, District of Columbia, United States, 20037
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33173
Anchor Research Center
Naples, Florida, United States, 34102
Central Florida Clinical Solutions
Ocoee, Florida, United States, 34761
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
Orlando Clinical Research Center
Orlando, Florida, United States, 32806
United States, Georgia
Medical Dietetics, Inc.
Atlanta, Georgia, United States, 30339
United States, Illinois
Springfield Diabetes and Endocrine Center
Springfield, Illinois, United States, 62704
United States, Indiana
Medical Research Consortium
Indianapolis, Indiana, United States, 46208
United States, Kansas
Wichita Clinic, PA
Wichita, Kansas, United States, 67208
United States, Kentucky
University of KY Internal Medicine
Lexington, Kentucky, United States, 40536-9841
United States, Louisiana
Pennington Center
Baton Rouge, Louisiana, United States, 70808
United States, Massachusetts
JM Clinical Trials, Inc.
Swansea, Massachusetts, United States, 02777
United States, Montana
Montana Medical Research, LLC
Missoula, Montana, United States, 59804
United States, New Hampshire
Endocrinology and Diabetes Consultants, PC
Dover, New Hampshire, United States, 03820
United States, New Jersey
Radiant Research
Lawrenceville, New Jersey, United States, 08648
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Central New York Clinical Research
Manlius, New York, United States, 13104
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
Comprehensive Weight Control Program
New York, New York, United States, 10021
United States, North Carolina
Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, United States, 28207
Multi-Specialty Research Associates of North Carolina
Raleigh, North Carolina, United States, 27609
United States, Ohio
Radiant Research
Columbus, Ohio, United States, 43212
Lindner Clinical Trials Center
Cincinnati, Ohio, United States, 45219
South Dayton Research Associates
Beavercreek, Ohio, United States, 45431
United States, Oregon
Radiant Research
Portland, Oregon, United States, 97201
United States, Pennsylvania
Radiant Research
Wyomissing, Pennsylvania, United States, 19610
SFM Clinical Trials
Scotland, Pennsylvania, United States, 17254
United States, Tennessee
Clinical Research Associates, Inc
Nashville, Tennessee, United States, 37203
ClinSearch
Chattanooga, Tennessee, United States, 37404
United States, Texas
Radiant Research
Austin, Texas, United States, 78758
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States, 75230
nTouch Research
Houston, Texas, United States, 77024
Quality Research, Inc.
San Antonio, Texas, United States, 78209
United States, Utah
Advanced Clinical Research
Salt Lake City, Utah, United States, 84102
United States, Virginia
Commonwealth Clinical Research Specialists (CCRS)
Richmond, Virginia, United States, 23226
United States, Washington
Rainer Clinical Research Center, Inc.
Renton, Washington, United States, 98055-5704
United States, Wisconsin
Clinical Nutrition Clinic, University of Wisconsin
Madison, Wisconsin, United States, 53705
Canada, Ontario
Group North
Windsor, Ontario, Canada, N8X3V6
Trial Management Group
Richmond Hill, Ontario, Canada, L4E3S8
Corunna Medical Clinic
Corunna, Ontario, Canada, N0N1G0
Quarry Family Medicine Clinic
Kingston, Ontario, Canada, K7L3E4

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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 controlled trial. JAMA. 2006 Feb 15;295(7):761-75. Erratum in: JAMA. 2006 Mar 15;295(11):1252.

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC4743
Study First Received:	January 23, 2002
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00029861 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Weight Loss
Obesity
Weight Reduction
Overweight

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on November 27, 2009