A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking

A Multicenter, Open-Label Study Exploring the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking

The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers. Safety is evaluated by adverse events, laboratory tests, and other safety tests.

Inclusion Criteria:

• Japanese smokers motivated to quit smoking
• No period without smoking of more than 3 months
• Smoked an average of at least 10 cigarettes/day in the past year

Exclusion Criteria:

• Subjects who have used nicotine replacement therapy within 1 month of the study screening visit
• Subjects intending to use nicotine replacement therapy or other smoking cessation treatments during the study