NCT00459173

Brief Summary

The primary study objective is to evaluate the efficacy of 2 dose levels of rimonabant (5 mg and 20 mg) for the maintenance of abstinence from smoking. Secondary objectives are to evaluate the effect of rimonabant on craving and weight, the clinical and biological safety of 2 doses of rimonabant rimonabant during a 12-month treatment period and to evaluate the pharmacokinetics of the drug.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,850

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2002

Typical duration for phase_3

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
Last Updated

April 7, 2009

Status Verified

April 1, 2009

Enrollment Period

2.8 years

First QC Date

April 10, 2007

Last Update Submit

April 6, 2009

Conditions

Maintenance of Smoking Cessation

Keywords

abstinencemaintenance

Outcome Measures

Primary Outcomes (2)

  • Time to smoking relapse from the point of re-randomization (Week 10) through Week 32

  • Smoking relapse defined as: any 7 or more consecutive days of smoking (even a puff) or any 2 consecutive days of smoking 5 or more cigarettes per day

Secondary Outcomes (2)

  • Efficacy: Time to smoking relapse from Week 10 to Week 52, craving, body weight change in abstainers, lipid parameters

  • Safety data

Interventions

rimonabant (SR141716)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis

Cove, New South Wales, Australia

Location

Sanofi-Aventis

Laval, Quebec, Canada

Location

MeSH Terms

Interventions

Rimonabant

Intervention Hierarchy (Ancestors)

PyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 11, 2007

Study Start

November 1, 2002

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

April 7, 2009

Record last verified: 2009-04

Locations

CA(1)US(1)AU(1)