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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 4, 2007
Last Update Posted: April 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
June 1, 2007
June 4, 2007
April 20, 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
Same as current
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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
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
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Not Provided
ICD Study Director, sanofi-aventis
Not Provided
Principal Investigator: John Blundell, Pr University of Leeds, United Kingdom
April 2009

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