Obese Patients With Untreated Dyslipidemias

NCT ID: NCT00029835

Last Updated: 2009-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1033 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2003-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Obesity Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Rimonabant (SR141716)

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Clinic of Physicians and Surgeons, LTD

Mesa, Arizona, United States

Site Status

Arizona Clinical Research Center, Inc.

Tucson, Arizona, United States

Site Status

Irvine Center for Clinical Research (ICCR)

Irvine, California, United States

Site Status

Los Angeles Clinical Trials

Los Angeles, California, United States

Site Status

Apexute

Santa Ana, California, United States

Site Status

Clinical Research of South Florida

Coral Gables, Florida, United States

Site Status

Radiant Research

Stuart, Florida, United States

Site Status

nTouch Research

Peoria, Illinois, United States

Site Status

nTouch Research

South Bend, Indiana, United States

Site Status

Bluegrass Clinical Research, Inc.

Louisville, Kentucky, United States

Site Status

Johns Hopkins Women's Research Core

Lutherville, Maryland, United States

Site Status

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status

Twin Cities Clinical Research

Arden Hills, Minnesota, United States

Site Status

Radiant Research

Edina, Minnesota, United States

Site Status

Women's Clinic of Lincoln, PC

Lincoln, Nebraska, United States

Site Status

New Mexico Clinical Research & Osteoporosis Center, Inc.

Albuquerque, New Mexico, United States

Site Status

Clinical Research Services

Bismarck, North Dakota, United States

Site Status

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Clinical Research Division

Newtown, Pennsylvania, United States

Site Status

Clinical Research Center of Reading, LLC

West Reading, Pennsylvania, United States

Site Status

Medical University of South Carolina, Division of Clinical Pharmacology

Charleston, South Carolina, United States

Site Status

Nashville Medical Research Institute

Nashville, Tennessee, United States

Site Status

Radiant Research

Salt Lake City, Utah, United States

Site Status

Clinical Research Center of Northern Virginia

Falls Church, Virginia, United States

Site Status

Hunter Holmes McGuire Medical Center Research Service (151)

Richmond, Virginia, United States

Site Status

Vancouver Medical Weight Loss Clinic

Vancouver, Washington, United States

Site Status

Addiction & Psychiatric Medicine Research

Morgantown, West Virginia, United States

Site Status

Sanofi-aventis Administrative Office

Macquarie Park, , Australia

Site Status

Sanofi-aventis Administrative Office

Laval, , Canada

Site Status

Sanofi-aventis Administrative Office

Helsinki, , Finland

Site Status

Sanofi-aventis Administrative Office

Milan, , Italy

Site Status

Sanofi-aventis Administrative Office

Barcelona, , Spain

Site Status

Sanofi-aventis Administrative Office

Bromma, , Sweden

Site Status

Sanofi-aventis Administrative Office

Geneva, , Switzerland

Site Status

Countries

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United States Australia Canada Finland Italy Spain Sweden Switzerland

References

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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. doi: 10.1056/NEJMoa044537.

Reference Type RESULT
PMID: 16291982 (View on PubMed)

Other Identifiers

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EFC4735

Identifier Type: -

Identifier Source: org_study_id

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