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Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation (STRATUS-EU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00464165
Recruitment Status : Completed
First Posted : April 23, 2007
Last Update Posted : December 10, 2010
Information provided by:

Brief Summary:

The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.

The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of abstinent subjects during a 40-week follow-up post treatment.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: rimonabant Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 789 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5mg/Day or 20mg/Day, Versus Placebo, as an Aid to Smoking Cessation; Multiple Country, Randomized, Double-blind, 3-arm, 10-week Treatment, 40-week Follow-up
Study Start Date : November 2002
Primary Completion Date : October 2003
Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements

Secondary Outcome Measures :
  1. Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence
  2. Safety data

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit
  • Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale

Exclusion Criteria:

  • Non tobacco cigarettes consumption
  • Chronic use of marijuana
  • Pregnancy, breastfeeding
  • Any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
  • Concomitant use of drugs as an aid to smoking cessation or that might induce weight change

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 identifier (NCT number): NCT00464165

Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Horsholm, Denmark
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sanofi-Aventis Administrative Office
Geneva, Switzerland
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT00464165     History of Changes
Other Study ID Numbers: EFC4474
First Posted: April 23, 2007    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2010

Keywords provided by Sanofi:

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