At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 593 enrolled
Drug / intervention
varenicline tartrate (CP-526, 555-18) +1 moredrug
Likely dose
varenicline tartrate (CP-526, 555-18) 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 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
In Brief
A Phase 4 clinical trial evaluating varenicline tartrate (CP-526, 555-18) and Placebo for Smoking Cessation. Completed, enrolled 593 participants across 42 sites in 11 countries.
Detailed Summary
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesBrazil, Colombia, Costa Rica, Egypt, Jordan, Lebanon, Mexico, Saudi Arabia, South Africa, United Arab Emirates, Venezuela
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2008
Enrollment StartApr 2008
Primary CompletionJun 2009
Study CompletionAug 2009
TodayJul 2026
First PostedJan 15, 2008
Enrollment StartApr 1, 2008
Primary CompletionJun 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.5 years ago
Interventions
varenicline tartrate (CP-526, 555-18)drug
1 mg twice a day for 12 weeks, starting with a 1-week titration period.
Placebodrug
matching placebo 1 tablet twice a day for 12 weeks