A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation
Status and phase
Completed
Phase 3
Conditions
Smoking Cessation
Treatments
Drug: varenicline (CP-526,555)
Details and patient eligibility
About
The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
Exclusion criteria
- Subjects with clinically significant cardiovascular disease in the past 6 months.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
24
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Data sourced from clinicaltrials.gov
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