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

Phase 3CompletedNCT00481923

Sanofi156 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

156

Conditions

Obesity

Interventions

rimonabant (SR141716)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis Administrative Office

Guildford, United Kingdom

Outcomes

Primary Outcomes

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 Outcomes

Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or "free-living" days

Clinical Safety

Data from ClinicalTrials.gov

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