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NCT00458718 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine Patch

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
755
Enrollment target

NCT00458718: Completed Phase 3 study, sponsored by Sanofi.

NCT00458718 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 755 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00458718, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
755 participants
Enrollment target

Study Summary

The primary objective is to compare the efficacy of rimonabant 20 mg OD fixed dose plus nicotine patch 21 mg OD with the combination rimonabant 20 mg OD fixed dose plus placebo patch on abstinence from smoking in cigarette smokers motivated to quit. Secondary objectives are to evaluate the clinical and biological safety of rimonabant associated with nicotine replacement therapy during a 9-week treatment period and to evaluate the effect of the combination on weight and craving.

Interventions

  • DRUG rimonabant (SR141716)

Trial Details

FieldValue
Enrollment Target 755 participants
Start Date 2004-09
Est. Completion 2005-07
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00458718 record still lists

NCT00458718 is an interventional study that assigns participants to a tested intervention. The registered 755 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which rimonabant (SR141716) is the first listed.

NCT00458718 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00458718 about?

NCT00458718 is a clinical study titled "Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine Patch". The primary objective is to compare the efficacy of rimonabant 20 mg OD fixed dose plus nicotine patch 21 mg OD with the combination rimonabant 20 mg OD fixed dose plus placebo patch on abstinence from smoking in cigarette smokers motivated to quit. Secondary objectives are to evaluate the clinical...

What is the current status of trial NCT00458718?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 755 participants. The study started on 2004-09. Estimated completion is 2005-07.

What interventions are being tested in trial NCT00458718?

The interventions under investigation include: rimonabant (SR141716) (DRUG).

Who is sponsoring clinical trial NCT00458718?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00458718's enrollment target sits among peer trials

755 459th of 2000 higher than 1,541 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00458718, the US trial registry maintained by the National Library of Medicine. NCT00458718 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.