Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT01244061
Start Date
December 1 2010
End Date
November 1 2012
Last Update
June 9 2014
Active Locations (37)
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1
Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095-6984
2
University of California Los Angeles David Geffen School of Medicine
Los Angeles, California, United States, 90095
3
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
4
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509