An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking
Intervention: Varenicline tartrate (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To investigate safety and efficacy of varenicline tartrate in helping people quit smoking
Clinical Details
Official title:
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
Secondary outcome: To gather safety data for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by 12 weeks of non-treatment follow-up.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Current cigarette smokers between the ages of 18 and 75 years, who are motivated to stop smoking
Exclusion Criteria:
- Patients currently suffering from depression, or have been diagnosed with depression in the last 12 months, or subjects with past or present history of psychosis, panic disorder, or bipolar disorder
- Any subject with known severe chronic obstructive pulmonary disease (COPD)
Locations and Contacts
Pfizer Investigational Site, Chiang Mai 50200, Thailand
Pfizer Investigational Site, Bangkok 10330, Thailand
Pfizer Investigational Site, Beijing 100020, China
Pfizer Investigational Site, Beijing 100036, China
Pfizer Investigational Site, Guangzhou 510120, China
Pfizer Investigational Site, Beijing 100853, China
Pfizer Investigational Site, Singapore 159964, Singapore
Pfizer Investigational Site, Singapore 169608, Singapore
Pfizer Investigational Site, Singapore 228310, Singapore
Pfizer Investigational Site, Shanghai 200233, China
Pfizer Investigational Site, Beijing 100029, China
Pfizer Investigational Site, Tanjin 300052, China
Pfizer Investigational Site, Shen Yang, Liao Ning 110001, China
Pfizer Investigational Site, Shenyang, Liaoning 110016, China
Additional Information
To obtain contact information for a study center near you, click here.
Starting date:
October 2006
Ending date: June 2007
Last updated: August 16, 2007
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