Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese Patients
Overview
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.
Full Title of Study: “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 Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: April 2005
Interventions
- Drug: rimonabant (SR141716)
Clinical Trial Outcome Measures
Primary 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 Measures
- Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or “free-living” days
- Clinical Safety
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Sanofi
- Provider of Information About this Clinical Study
- ICD Study Director, sanofi-aventis
- Overall Official(s)
- John Blundell, Pr, Principal Investigator, University of Leeds, United Kingdom
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