At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 498 enrolled
Drug / intervention
Varenicline +1 moredrug
Likely dose
Varenicline 1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline
In Brief
A Phase 4 clinical trial evaluating Varenicline and Placebo for Smoking Cessation. Completed, enrolled 498 participants across 37 sites in 8 countries.
Detailed Summary
The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesAustralia, Belgium, Canada, Czechia, France, Germany, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2010
Enrollment StartDec 2010
Primary CompletionNov 2012
TodayJul 2026
First PostedNov 19, 2010
Enrollment StartDec 1, 2010
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.6 years ago
Interventions
Vareniclinedrug
Varenicline 1mg twice daily
Placebodrug
Matched placebo twice daily