Obese Patients With Untreated Dyslipidemias - Full Text View

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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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Locations

United States, Arizona
Clinic of Physicians and Surgeons, LTD
Mesa, Arizona, United States, 85201
Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85712
United States, California
Los Angeles Clinical Trials
Los Angeles, California, United States, 90064
Irvine Center for Clinical Research (ICCR)
Irvine, California, United States, 92618
Apexute
Santa Ana, California, United States, 92705
United States, Florida
Radiant Research
Stuart, Florida, United States, 34996
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
United States, Illinois
nTouch Research
Peoria, Illinois, United States, 61602
United States, Indiana
nTouch Research
South Bend, Indiana, United States, 46601
United States, Kentucky
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States, 40291
United States, Maryland
Johns Hopkins Women's Research Core
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Minnesota
Twin Cities Clinical Research
Arden Hills, Minnesota, United States, 55126
Radiant Research
Edina, Minnesota, United States, 55435
United States, Nebraska
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, United States, 68510
United States, New Mexico
New Mexico Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, United States, 87106
United States, North Dakota
Clinical Research Services
Bismarck, North Dakota, United States, 58501
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267-0559
United States, Pennsylvania
Clinical Research Center of Reading, LLC
West Reading, Pennsylvania, United States, 19611-1124
Clinical Research Division
Newtown, Pennsylvania, United States, 18940
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Medical University of South Carolina, Division of Clinical Pharmacology
Charleston, South Carolina, United States, 29425
United States, Tennessee
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37205
United States, Utah
Radiant Research
Salt Lake City, Utah, United States, 84111
United States, Virginia
Clinical Research Center of Northern Virginia
Falls Church, Virginia, United States, 22044
Hunter Holmes McGuire Medical Center Research Service (151)
Richmond, Virginia, United States, 23249
United States, Washington
Vancouver Medical Weight Loss Clinic
Vancouver, Washington, United States, 98685
United States, West Virginia
Addiction & Psychiatric Medicine Research
Morgantown, West Virginia, United States, 26506-9300
Australia
Sanofi-aventis Administrative Office
Macquarie Park, Australia
Canada
Sanofi-aventis Administrative Office
Laval, Canada
Finland
Sanofi-aventis Administrative Office
Helsinki, Finland
Italy
Sanofi-aventis Administrative Office
Milano, Italy
Spain
Sanofi-aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-aventis Administrative Office
Bromma, Sweden
Switzerland
Sanofi-aventis Administrative Office
Geneva, Switzerland

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:

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

Keywords provided by Sanofi-Aventis:

Obesity

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Nutrition Disorders

Overweight
Overnutrition
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009