CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 525 enrolled
Drug / intervention
varenicline +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.

Search/NCT01078298
NCT01078298Phase 4Completed
CompareCT.gov

A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression

Pfizer·interventional·Posted Mar 2, 2010·Updated Apr 16, 2013

In Brief

A Phase 4 clinical trial evaluating varenicline and placebo for Smoking Cessation and Depression. Completed, enrolled 525 participants across 41 sites in 8 countries.

Detailed Summary

Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation, Depression
CountriesBosnia and Herzegovina, Croatia, Germany, Hungary, Romania, Russia, Spain, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2010
Enrollment StartMar 1, 2010
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.3 years ago

Interventions

vareniclinedrug

varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks

placebodrug

placebo tablets matched in appearance and dosage to varenicline tablets