Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).
NCT00285012
ABOUT THIS STUDY
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- Subjects will be current cigarette smokers who have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit.
- mild to moderate COPD confirmed by spirometry
- Subjects must have a clinical diagnosis of COPD.
- Subjects who have made a serious attempt to quit smoking in the past 3 months.
- Subjects who have been previously randomized in a study that has included varenicline.
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Descriptive Information | ||||
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Brief Title ICMJE | Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD). | |||
Official Title ICMJE | A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With 40-Week Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate For Smoking Cessation In Patients With Mild-To-Moderate Chronic Obstructive Pulmonary Disease | |||
Brief Summary | This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Smoking Cessation | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | |||
Actual Enrollment ICMJE | 504 | |||
Original Enrollment ICMJE | 500 | |||
Actual Study Completion Date ICMJE | April 2009 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 35 Years and older (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 | France, Italy, Spain, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00285012 | |||
Other Study ID Numbers ICMJE | A3051054 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | April 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |