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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3045

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Change in body weight

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Metabolic parameters

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2002

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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