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Obese Patients With Untreated Dyslipidemias (RIO-Lipids)

This study has been completed.
Study NCT00029835.   Last updated on June 6, 2008.   Information provided by Sanofi-Aventis

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Descriptive Information Fields
Brief Title  Obese Patients With Untreated Dyslipidemias
Official Title  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
Brief Summary

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

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Change from baseline in body weight at 1 year.
Secondary Outcome Measure  Metabolic parameters
Condition  Obesity
Dyslipidemia
Intervention  Drug: Rimonabant (SR141716)
MEDLINE PMIDs 16291982
Links Related Info This link exits the ClinicalTrials.gov site
Related Info This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  1033
Start Date  September 2001
Completion Date November 2003
Eligibility Criteria 
  • 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)
Gender Both
Ages 18 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Australia,   Canada,   Finland,   Italy,   Spain,   Sweden,   Switzerland
Administrative Information Fields
NCT ID  NCT00029835
Organization ID EFC4735
Secondary IDs †† SR141716
Study Sponsor  Sanofi-Aventis
Collaborators ††
Investigators 
Study Director:     ICD CSD     Sanofi-Aventis    
Information Provided By Sanofi-Aventis
Verification Date June 2008
First Received Date  January 23, 2002
Last Updated Date June 6, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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