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Completed

NCT Number: NCT00481923

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office

Guildford, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rimonabant (SR141716)

Drug

Primary outcomes

  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 outcomes

  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

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Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: REBA

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 4, 2007
Registry last updated
Apr 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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