The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
600
Pfizer Investigational Site
Noda, Chiba, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
4-week continuous quit rate (CQR) for Weeks 9-12
Continuous abstinence for Weeks 9-52 and Weeks 9-24
Long-term quit rate at Week 52
4-week CQR for Weeks 4-7
7-day point prevalence of asbtinence Weeks 12, Week 24, and Week 52
Continuous abstinence from TQD (Week 1) through Week 12
Weekly average number of cigarettes smoked per day for Weeks 1-12
Evaluation of withdrawal symptoms by the Minnesota Nicotine Withdrawal Scale
Evaluation of smoking satisfaction by the Smoking Effects Inventory
Evaluation of urge to smoke by the Brief Questionnaire of Smoking Urges
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Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Ohita, Ohita, Japan
Pfizer Investigational Site
Beppu-shi, Oita Prefecture, Japan
Pfizer Investigational Site
Toyonaka, Osaka, Japan
Pfizer Investigational Site
Tosu, Saga-ken, Japan
Pfizer Investigational Site
Hamamatsu, Shizuoka, Japan
Pfizer Investigational Site
Edogawa-ku, Tokyo, Japan
...and 5 more locations