Obese Patients With Untreated Dyslipidemias - Tabular View

Tracking Information

First Received Date ^ICMJE

January 23, 2002

Last Updated Date

April 17, 2009

Start Date ^ICMJE

September 2001

Primary Completion Date

November 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in body weight at 1 year.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00029835 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Metabolic parameters

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Obese Patients With Untreated Dyslipidemias

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obesity
Dyslipidemia

Intervention ^ICMJE

Drug: Rimonabant (SR141716)

Study Arms / Comparison Groups

Publications *

Despres JP, Golay A, Sjostrom L; Rimonabant in Obesity-Lipids Study Group. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med. 2005 Nov 17;353(20):2121-34.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1033

Completion Date

November 2003

Primary Completion Date

November 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada, Finland, Italy, Spain, Sweden, Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00029835

Responsible Party

ICD Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

EFC4735

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP