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NCT00358228 · ClinicalTrials.gov registry record · Phase 3
Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Smoking Cessation (STRATUS US)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 787
- Enrollment target
NCT00358228 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 787 participants.
The verdict
NCT00358228, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 787 participants
- Enrollment target
Study Summary
The primary study objective was to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers. The secondary study objectives were: * To evaluate the effects of rimonabant on craving and weight; * To evaluate the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period * To evaluate the population pharmacokinetics of rimonabant (ie, standard PK evaluation in the population of smokers); * To observe the percentage of abstinent patients during a 40-week follow-up post treatment period; * To evaluate quality of life (QOL) and pharmacoeconomics.
Interventions
- DRUG Rimonabant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 787 participants |
| Start Date | 2002-09 |
| Est. Completion | 2003-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00358228
The ClinicalTrials.gov registry entry for NCT00358228 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 787 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rimonabant is the first listed.
NCT00358228 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00358228 about?
NCT00358228 is a clinical study titled "Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Smoking Cessation (STRATUS US)". The primary study objective was to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers. The secondary study objectives were: * To evaluate the effects of rimonabant on craving and weight; * To evaluate the clinical and biological sa...
What is the current status of trial NCT00358228?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 787 participants. The study started on 2002-09. Estimated completion is 2003-08.
What interventions are being tested in trial NCT00358228?
The interventions under investigation include: Rimonabant (DRUG).
Who is sponsoring clinical trial NCT00358228?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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