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

NCT ID: NCT00029861

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

3045 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2004-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Obesity Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Rimonabant (SR141716)

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 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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Radiant Research

Birmingham, Alabama, United States

Site Status

Radiant Research

Phoenix, Arizona, United States

Site Status

East Bay Clinical Trial Center

Concord, California, United States

Site Status

Feighner Research Institute

San Diego, California, United States

Site Status

Scripps Clinic

San Diego, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Ranch View Family Medicine

Highlands Ranch, Colorado, United States

Site Status

Longmont Medical Research Network

Longmont, Colorado, United States

Site Status

Health Core, Inc.

Newark, Delaware, United States

Site Status

George Washington Univ. Wieght Mmgt Program

Washington D.C., District of Columbia, United States

Site Status

Miami Research Associates

Miami, Florida, United States

Site Status

Anchor Research Center

Naples, Florida, United States

Site Status

Central Florida Clinical Solutions

Ocoee, Florida, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Palm Beach Research Center

West Palm Beach, Florida, United States

Site Status

Medical Dietetics, Inc.

Atlanta, Georgia, United States

Site Status

Springfield Diabetes and Endocrine Center

Springfield, Illinois, United States

Site Status

Medical Research Consortium

Indianapolis, Indiana, United States

Site Status

Wichita Clinic, PA

Wichita, Kansas, United States

Site Status

University of KY Internal Medicine

Lexington, Kentucky, United States

Site Status

Pennington Center

Baton Rouge, Louisiana, United States

Site Status

JM Clinical Trials, Inc.

Swansea, Massachusetts, United States

Site Status

Montana Medical Research, LLC

Missoula, Montana, United States

Site Status

Endocrinology and Diabetes Consultants, PC

Dover, New Hampshire, United States

Site Status

Radiant Research

Lawrenceville, New Jersey, United States

Site Status

Lovelace Scientific Resources

Albuquerque, New Mexico, United States

Site Status

Central New York Clinical Research

Manlius, New York, United States

Site Status

Comprehensive Weight Control Program

New York, New York, United States

Site Status

St. Luke's Roosevelt Hospital Center

New York, New York, United States

Site Status

Center for Nutrition and Preventive Medicine

Charlotte, North Carolina, United States

Site Status

Multi-Specialty Research Associates of North Carolina

Raleigh, North Carolina, United States

Site Status

South Dayton Research Associates

Beavercreek, Ohio, United States

Site Status

Lindner Clinical Trials Center

Cincinnati, Ohio, United States

Site Status

Radiant Research

Columbus, Ohio, United States

Site Status

Radiant Research

Portland, Oregon, United States

Site Status

SFM Clinical Trials

Scotland, Pennsylvania, United States

Site Status

Radiant Research

Wyomissing, Pennsylvania, United States

Site Status

ClinSearch

Chattanooga, Tennessee, United States

Site Status

Clinical Research Associates, Inc

Nashville, Tennessee, United States

Site Status

Radiant Research

Austin, Texas, United States

Site Status

Dallas Diabetes and Endocrine Center

Dallas, Texas, United States

Site Status

nTouch Research

Houston, Texas, United States

Site Status

Quality Research, Inc.

San Antonio, Texas, United States

Site Status

Advanced Clinical Research

Salt Lake City, Utah, United States

Site Status

Commonwealth Clinical Research Specialists (CCRS)

Richmond, Virginia, United States

Site Status

Rainer Clinical Research Center, Inc.

Renton, Washington, United States

Site Status

Clinical Nutrition Clinic, University of Wisconsin

Madison, Wisconsin, United States

Site Status

Corunna Medical Clinic

Corunna, Ontario, Canada

Site Status

Quarry Family Medicine Clinic

Kingston, Ontario, Canada

Site Status

Trial Management Group

Richmond Hill, Ontario, Canada

Site Status

Group North

Windsor, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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. doi: 10.1001/jama.295.7.761.

Reference Type RESULT
PMID: 16478899 (View on PubMed)

Other Identifiers

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EFC4743

Identifier Type: -

Identifier Source: org_study_id

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