Comparison of Efficacy and Safety of Rimonabant 20mg/Day Versus Placebo in Smoking Cessation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

533 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2004-11-30

Brief Summary

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The primary objective is to assess the efficacy a 20mg/day fixed dose of rimonabant versus placebo on abstinence from tobacco use in cigarette smoker.

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.

Detailed Description

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Conditions

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Smoking Cessation

Keywords

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abstinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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rimonabant

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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SR141716

Identifier Type: -

Identifier Source: secondary_id

EFC5794