Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00386061
First received: October 10, 2006
Last updated: April 17, 2009
Last verified: April 2009

October 10, 2006
April 17, 2009
October 2001
June 2004   (final data collection date for primary outcome measure)
change in body weight from baseline to 1 year.
Same as current
Complete list of historical versions of study NCT00386061 on ClinicalTrials.gov Archive Site
HDL-C and TG from baseline to 1 year; ·patients (%) with improvement of glucose tolerance, patients (%) with NCEP-ATPIII metabolic syndrome at 1 year.
Same as current
Not Provided
Not Provided
 
Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety of SR141716 in Obese Patients With or Without Comorbidities (RIO-Europe)

The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities.

The main secondary objectives were to assess the effect of SR141716 on lipid parameters (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist circumference, glycemic parameters.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obesity
Drug: rimonabant (SR141716)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1507
June 2004
June 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • body mass index (BMI) e30 kg/m2 in patients with or without comorbidities, or BMI >27 kg/m2 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia.
  • stable body weight (variation <5 kg within 3 months prior to screening visit);

Exclusion Criteria:

  • History of very low-calorie diet within 6 months prior to screening visit; or history of surgical procedures for body weight loss (eg, stomach stapling, bypass);
  • Presence of any clinically significant psychiatric , neurological or endocrine disease
  • Presence of treated or untreated type 1 or type 2 diabetes);
  • SBP >165 mmHg and/or DBP >105 mmHg on 2 consecutive visits from the screening to the inclusion visit;
  • History of myocardial infarction or unstable angina pectoris within 6 months prior to screening visit; and history of stroke within 6 months prior to screening visit;
  • Administration of anti-obesity drugs or other drugs for body weight reduction within 3 months prior to screening visit;

The investigator will evaluate whether there are other reasons why a patient may not participate.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Finland,   France,   Germany,   Netherlands,   Sweden
 
NCT00386061
EFC4733
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
April 2009

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