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Study 1 of 18 for search of: | United Arab Emirates |
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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00594204 |
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.
Condition | Intervention | Phase |
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Smoking Cessation |
Drug: varenicline tartrate (CP-526, 555-18) Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate 1 Mg Bid For Smoking Cessation |
Estimated Enrollment: | 600 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Active Comparator |
Drug: varenicline tartrate (CP-526, 555-18)
1 mg twice a day for 12 weeks, starting with a 1-week titration period.
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II: Placebo Comparator |
Drug: Placebo
matching placebo 1 tablet twice a day for 12 weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3051080 |
Study First Received: | January 3, 2008 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00594204 |
Health Authority: | Brazil: National Committee of Ethics in Research; Brazil: National Health Surveillance Agency |
Smoking |
Habits |