At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,510 enrolled
Drug / intervention
Varenicline Tartrate +1 moredrug
Likely dose
Varenicline Tartrate 0.5mgfrom 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, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
In Brief
A Phase 4 clinical trial evaluating Varenicline Tartrate and Placebo for Smoking Cessation. Completed, enrolled 1,510 participants across 65 sites in 10 countries.
Detailed Summary
This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesAustralia, Canada, Czechia, Egypt, Germany, Japan, Mexico, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartJul 2011
Primary CompletionJul 2013
TodayJul 2026
First PostedJun 9, 2011
Enrollment StartJul 1, 2011
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.1 years ago
Interventions
Varenicline Tartratedrug
Varenicline Tartrate oral tablets 2 (0.5mg) tablets twice a day for 24 weeks (first week titration)
Placebodrug
Matching placebo 2 oral tablets twice a day for 24 weeks (first week titration)