At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 659 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
varenicline 1 mgfrom 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, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
In Brief
A Phase 4 clinical trial evaluating placebo and varenicline for Smoking Cessation. Completed, enrolled 659 participants across 33 sites in 14 countries.
Detailed Summary
The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesArgentina, Brazil, Canada, China, Czechia, France, Germany, Hungary, Italy, Mexico, South Korea, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2008
Enrollment StartSep 2008
Primary CompletionSep 2009
Study CompletionDec 2009
TodayJul 2026
First PostedJun 5, 2008
Enrollment StartSep 1, 2008
Primary CompletionSep 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.1 years ago
Interventions
placebodrug
placebo tablet taken orally twice daily for 12 weeks
vareniclinedrug
varenicline tablets, 1 mg taken orally twice daily for 12 weeks