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Obese Patients with or without Comorbidities - Article


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Clinical Trial: Obese Patients with or without Comorbidities

This study has been completed.

Sponsored by: Sanofi-Synthelabo
Information provided by: Sanofi-Synthelabo

Purpose

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

Condition Treatment or Intervention Phase
Obesity
Weight Loss
 Drug: Rimonabant
Phase III

MedlinePlus related topics:  Obesity;   Weight Loss and Dieting

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: 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

Further Study Details: 

Expected Total Enrollment:  2800

Study start: August 2001;  Study completion: March 2002

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Location Information


Alabama
      Radiant Research, Birmingham,  Alabama,  35209,  United States

Arizona
      Radiant Research, Phoenix,  Arizona,  85013,  United States

California
      Diablo Clinical Research, Inc., Walnut Creek,  California,  94598,  United States

      East Bay Clinical Trial Center, Concord,  California,  94520,  United States

      Scripps Clinic, San Diego,  California,  92130,  United States

      Feighner Research Institute, San Diego,  California,  92121,  United States

Colorado
      Longmont Medical Research Network, Longmont,  Colorado,  80501,  United States

      Ranch View Family Medicine, Highlands Ranch,  Colorado,  80130,  United States

Delaware
      Health Core, Inc., Newark,  Delaware,  19713,  United States

District of Columbia
      George Washington Univ. Wieght Mmgt Program, Washington,  District of Columbia,  20037,  United States

Florida
      Miami Research Associates, Miami,  Florida,  33173,  United States

      Anchor Research Center, Naples,  Florida,  34102,  United States

      Central Florida Clinical Solutions, Ocoee,  Florida,  34761,  United States

      Palm Beach Research Center, West Palm Beach,  Florida,  33409,  United States

      Orlando Clinical Research Center, Orlando,  Florida,  32806,  United States

Georgia
      Medical Dietetics, Inc., Atlanta,  Georgia,  30339,  United States

Illinois
      Springfield Diabetes and Endocrine Center, Springfield,  Illinois,  62704,  United States

Indiana
      Medical Research Consortium, Indianapolis,  Indiana,  46208,  United States

Kansas
      Wichita Clinic, PA, Wichita,  Kansas,  67208,  United States

Kentucky
      University of KY Internal Medicine, Lexington,  Kentucky,  40536-9841,  United States

Louisiana
      Pennington Center, Baton Rouge,  Louisiana,  70808,  United States

Massachusetts
      JM Clinical Trials, Inc., Swansea,  Massachusetts,  02777,  United States

Montana
      Montana Medical Research, LLC, Missoula,  Montana,  59804,  United States

New Hampshire
      Endocrinology and Diabetes Consultants, PC, Dover,  New Hampshire,  03820,  United States

New Jersey
      Radiant Research, Lawrenceville,  New Jersey,  08648,  United States

New Mexico
      Lovelace Scientific Resources, Albuquerque,  New Mexico,  87108,  United States

New York
      Central New York Clinical Research, Manlius,  New York,  13104,  United States

      St. Luke's Roosevelt Hospital Center, New York,  New York,  10025,  United States

      Comprehensive Weight Control Program, New York,  New York,  10021,  United States

North Carolina
      Center for Nutrition and Preventive Medicine, Charlotte,  North Carolina,  28207,  United States

      Multi-Specialty Research Associates of North Carolina, Raleigh,  North Carolina,  27609,  United States

Ohio
      Radiant Research, Columbus,  Ohio,  43212,  United States

      Lindner Clinical Trials Center, Cincinnati,  Ohio,  45219,  United States

      South Dayton Research Associates, Beavercreek,  Ohio,  45431,  United States

Oregon
      Radiant Research, Portland,  Oregon,  97201,  United States

Pennsylvania
      Radiant Research, Wyomissing,  Pennsylvania,  19610,  United States

      SFM Clinical Trials, Scotland,  Pennsylvania,  17254,  United States

Tennessee
      Clinical Research Associates, Inc, Nashville,  Tennessee,  37203,  United States

      ClinSearch, Chattanooga,  Tennessee,  37404,  United States

Texas
      Radiant Research, Austin,  Texas,  78758,  United States

      Dallas Diabetes and Endocrine Center, Dallas,  Texas,  75230,  United States

      nTouch Research, Houston,  Texas,  77024,  United States

      Quality Research, Inc., San Antonio,  Texas,  78209,  United States

Utah
      Advanced Clinical Research, Salt Lake City,  Utah,  84102,  United States

Virginia
      Commonwealth Clinical Research Specialists (CCRS), Richmond,  Virginia,  23226,  United States

Washington
      Rainer Clinical Research Center, Inc., Renton,  Washington,  98055-5704,  United States

Wisconsin
      Clinical Nutrition Clinic, University of Wisconsin, Madison,  Wisconsin,  53705,  United States

Canada, Ontario
      Group North, Windsor,  Ontario,  N8X3V6,  Canada

      Trial Management Group, Richmond Hill,  Ontario,  L4E3S8,  Canada

      Corunna Medical Clinic, Corunna,  Ontario,  N0N1G0,  Canada

      Quarry Family Medicine Clinic, Kingston,  Ontario,  K7L3E4,  Canada

More Information

http://sanofi-synthelabous.com

http://centerwatch.com

Study ID Numbers:  EFC4743; SR141716
Record last reviewed:  November 2002
Last Updated:  October 13, 2004
Record first received:  January 23, 2002
ClinicalTrials.gov Identifier:  NCT00029861
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 12, 2008



Page Updated: June 12, 2007
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