A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

Status:	Completed
Conditions:	Smoking Cessation
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	Any
Updated:	11/18/2012
Start Date:	December 2010
End Date:	November 2012
Contact:	Pfizer CT.gov Call Center
Phone:	1-800-718-1021

A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline

The main purpose of this study is to compare the effectiveness and safety of the
re-treatment of smokers with varenicline with placebo for smoking cessation during the last
4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain
abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the
end of treatment).

Inclusion Criteria:

- Smokers aged 18 years or above and wanting to stop smoking

- Smokers who have smoked an average of at least 10 cigarettes per day over the last 4
weeks

- Smokers who have tried before to stop smoking at least once with varenicline, and who
took varenicline for at least 2 weeks

- The last attempt to stop smoking must be at least 3 months before entering the study

Exclusion Criteria:

- Individuals who have not tolerated varenicline well previously, or who have a current
or prior medical or psychiatric history that would make entry into the trial
inadvisable

- Individuals who have previously participated in clinical trials of varenicline

- Individuals who have been participating in another smoking cessation trial within the
last 3 months, or other drug trial within the last 30 days

We found this trial at

sites

Clinical Research Associates, Inc.

1500 Church Street
Metropolitan Government, Tennessee 37203

615-329-2222