At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 504 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
placebo 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 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With 40-Week Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate For Smoking Cessation In Patients With Mild-To-Moderate Chronic Obstructive Pulmonary Disease
In Brief
A Phase 3 clinical trial evaluating placebo and Varenicline Tartarate for Smoking Cessation. Completed, enrolled 504 participants across 32 sites in 4 countries.
Detailed Summary
This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesFrance, Italy, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2006
Enrollment StartMay 2006
Primary CompletionJul 2008
Study CompletionApr 2009
TodayJul 2026
First PostedFeb 1, 2006
Enrollment StartMay 1, 2006
Primary CompletionJul 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 20.4 years ago
Interventions
placebodrug
1mg (placebo) by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
Varenicline Tartaratedrug
1 mg by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)