CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 312 enrolled
Drug / intervention
Varenicline 1mg BID +2 moredrug
Likely dose
Varenicline 1mg BIDfrom 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/NCT01312909
NCT01312909Phase 4Completed
CompareCT.gov

A Twelve-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study With Follow-up Evaluating The Safety And Efficacy Of Varenicline For Smoking Cessation In Healthy Adolescent Smokers

Pfizer·interventional·Posted Mar 11, 2011·Updated Aug 9, 2018

In Brief

A Phase 4 clinical trial evaluating Varenicline 1mg BID, Varenicline 0.5mg BID, and 1 other intervention for Smoking Cessation. Completed, enrolled 312 participants across 80 sites in 6 countries.

Detailed Summary

The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesCanada, Georgia, Russia, South Korea, Taiwan, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2011
Enrollment StartApr 1, 2011
Primary CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 15.3 years ago

Interventions

Varenicline 1mg BIDdrug

Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52

Varenicline 0.5mg BIDdrug

Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52

Placebodrug

Oral placebo for twelve weeks,follow-up through Week 52