Obese Patients With Untreated Dyslipidemias (RIO-Lipids)

April 17, 2009 updated by: Sanofi

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1033

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in body weight at 1 year.

Secondary Outcome Measures

Outcome Measure
Metabolic parameters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

November 1, 2003

Study Completion (Actual)

November 1, 2003

Study Registration Dates

First Submitted

January 23, 2002

First Submitted That Met QC Criteria

January 23, 2002

First Posted (Estimate)

January 24, 2002

Study Record Updates

Last Update Posted (Estimate)

April 20, 2009

Last Update Submitted That Met QC Criteria

April 17, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC4735

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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