Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese Patients (REBA)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00481923
First received: June 1, 2007
Last updated: April 17, 2009
Last verified: April 2009

June 1, 2007
April 17, 2009
May 2004
April 2005   (final data collection date for primary outcome measure)
Absolute change from baseline in energy intake during ad-libitum dinner of the high-fat probe day at Weeks 3/4 of double-blind treatment.
Same as current
Complete list of historical versions of study NCT00481923 on ClinicalTrials.gov Archive Site
  • Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or "free-living" days
  • Clinical Safety
  • Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or “free-living” days
  • Clinical Safety
Not Provided
Not Provided
 
Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese Patients
A Randomized, Double-Bind, Placebo-Controlled, Parallel-Group, Fixed-Dose (20 mg/Day), 3-Month, Multicenter Study of the Energy Intake Effects and Safety of SR141716 With or Without Hypocaloric Diet in Obese Patients

The primary objective of this study is to assess the effect of rimonabant on the energy intake (kcal/day/meal) from ad-libitum high-fat dinner (primary endpoint), pre- and post-ingestive responses, and the hedonic evaluation of food, and its effect on food choice, cravings and feelings of control.

The secondary objectives are to determine the effect of rimonabant on body weight with or without hypocaloric diet and its clinical and laboratory safety.

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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
April 2005
April 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obese subjects with Body Mass Index ≥ 30 and < 45 kg/m²

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00481923
EFC5031
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Principal Investigator: John Blundell, Pr University of Leeds, United Kingdom
Sanofi
April 2009

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