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

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ClinicalTrials.gov Identifier: NCT00481923
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : April 20, 2009
Sponsor:
Information provided by:
Sanofi

Brief Summary:

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 or disease Intervention/treatment Phase
Obesity Drug: rimonabant (SR141716) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
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
Study Start Date : May 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005



Primary Outcome Measures :
  1. 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 :
  1. Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or "free-living" days
  2. Clinical Safety


Information from the National Library of Medicine

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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481923


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

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00481923     History of Changes
Other Study ID Numbers: EFC5031
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: April 20, 2009
Last Verified: April 2009

Keywords provided by Sanofi:
hypocaloric diet
energy intake

Additional relevant MeSH terms:
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs