A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation
NCT00143286
ABOUT THIS STUDY
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- Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
- Subjects with clinically significant cardiovascular disease in the past 6 months.
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Descriptive Information | ||||
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Brief Title ICMJE | A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation | |||
Official Title ICMJE | A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation | |||
Brief Summary | The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Smoking Cessation | |||
Intervention ICMJE | Drug: varenicline (CP-526,555) | |||
Study Arms ICMJE | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 2000 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, Czech Republic, Denmark, Norway, Sweden, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00143286 | |||
Other Study ID Numbers ICMJE | A3051035 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | June 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |