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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Smoking

Treatments: Drug: Varenicline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00635401

A3051043

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

0.5 mg BID

Experimental group

Treatment:

Drug: Varenicline