Obese Patients With Untreated Dyslipidemias (RIO-Lipids)

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ClinicalTrials.gov Identifier: NCT00029835

Recruitment Status : Completed

First Posted : January 24, 2002

Last Update Posted : April 20, 2009

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

Sanofi

Tracking Information

First Submitted Date ^ICMJE

January 23, 2002

First Posted Date ^ICMJE

January 24, 2002

Last Update Posted Date

April 20, 2009

Study Start Date ^ICMJE

September 2001

Actual 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

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Metabolic parameters

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Obesity
Dyslipidemia

Intervention ^ICMJE

Drug: Rimonabant (SR141716)

Study Arms ^ICMJE

Not Provided

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. doi: 10.1056/NEJMoa044537.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

1033

Original Enrollment ^ICMJE

370

Actual Study Completion Date ^ICMJE

November 2003

Actual 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)

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 70 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

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

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00029835

Other Study ID Numbers ^ICMJE

EFC4735

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

ICD Study Director, sanofi-aventis

Original Responsible Party

Not Provided

Current Study Sponsor ^ICMJE

Sanofi

Original Study Sponsor ^ICMJE

Sanofi-Synthelabo

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi

PRS Account

Sanofi

Verification Date

April 2009

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

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