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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
- 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.
- Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or "free-living" days
- Clinical Safety
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
|Sanofi-Aventis Administrative Office|
|Guilford, United Kingdom|
|Principal Investigator:||John Blundell, Pr||University of Leeds, United Kingdom|