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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00635401 |
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.
Condition | Intervention | Phase |
---|---|---|
Smoking |
Drug: Varenicline |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Open-Label Study Exploring the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking |
Enrollment: | 30 |
Study Start Date: | May 2004 |
Study Completion Date: | August 2004 |
Arms | Assigned Interventions |
---|---|
0.5 mg BID: Experimental |
Drug: Varenicline
0.5 mg BID for 7 weeks
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Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Pfizer Investigational Site | |
OITA, Japan | |
Japan, FUKUOKA | |
Pfizer Investigational Site | |
CHUO-KU FUKUOKA, FUKUOKA, Japan | |
Japan, KANAGAWA | |
Pfizer Investigational Site | |
NISHI-KU YOKOHAMA, KANAGAWA, Japan | |
Japan, OITA | |
Pfizer Investigational Site | |
BEPPU, OITA, Japan | |
Japan, Shizuoka-Ken | |
Pfizer Investigational Site | |
HAMAMATSU-SHI, Shizuoka-Ken, Japan | |
Japan, TOKYO | |
Pfizer Investigational Site | |
MINATO-KU, TOKYO, Japan | |
Pfizer Investigational Site | |
EDOGAWA-KU, TOKYO, Japan | |
Japan, Tokyo | |
Pfizer Investigational Site | |
Toshima-ku, Tokyo, Japan |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3051043 |
Study First Received: | March 5, 2008 |
Last Updated: | April 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00635401 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Smoking |
Habits |