Obese Patients With Untreated Dyslipidemias - Tabular View

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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

This Tabular View shows the required WHO registration data elements as marked by ^†

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

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

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.