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

April 17, 2009 updated by: Sanofi

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3045

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

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

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in body weight

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

August 1, 2001

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

April 1, 2004

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

  • EFC4743

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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