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

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

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.

Condition Intervention Phase
Obesity Drug: rimonabant (SR141716) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or "free-living" days
  • Clinical Safety

Enrollment: 156
Study Start Date: May 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00481923

United Kingdom
Sanofi-Aventis Administrative Office
Guilford, United Kingdom
Sponsors and Collaborators
Principal Investigator: John Blundell, Pr University of Leeds, United Kingdom
  More Information

Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00481923     History of Changes
Other Study ID Numbers: EFC5031
Study First Received: June 1, 2007
Last Updated: April 17, 2009

Keywords provided by Sanofi:
hypocaloric diet
energy intake

Additional relevant MeSH terms:
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 19, 2017