At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 4,595 enrolled
Drug / intervention
placebo +3 moredrug
Likely dose
Not stated in 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, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders
In Brief
A Phase 4 clinical trial evaluating placebo, varenicline tartrate, and 2 other interventions for Smoking Cessation. Completed, enrolled 4,595 participants across 134 sites in 16 countries.
Detailed Summary
Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesArgentina, Australia, Brazil, Bulgaria, Canada, Chile, Denmark, Finland, Germany, Mexico, New Zealand, Russia, Slovakia, South Africa, Spain, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2012
Enrollment StartMay 2012
Primary CompletionJul 2015
TodayJul 2026
First PostedApr 10, 2012
Enrollment StartMay 1, 2012
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.2 years ago
Interventions
placebodrug
All dosing to have taken place per study A3051123
varenicline tartratedrug
All dosing to have taken place per study A3051123
bupropion hydrochloridedrug
All dosing to have taken place per study A3051123
Nicotine Replacement Therapy Patchdrug
All dosing to have taken place per study A3051123