- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00143299
A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline
June 1, 2007 updated by: Pfizer
A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation
The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
375
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Australia
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Woodville South, South Australia, Australia, 5011
- Pfizer Investigational Site
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Colorado
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Denver, Colorado, United States, 80212
- Pfizer Investigational Site
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Massachusetts
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Milford, Massachusetts, United States, 01757
- Pfizer Investigational Site
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New Mexico
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Albuquerque, New Mexico, United States, 87108
- Pfizer Investigational Site
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New York
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Syracuse, New York, United States, 13210
- Pfizer Investigational Site
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Pfizer Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- Pfizer Investigational Site
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Pennsylvania
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Harleysville, Pennsylvania, United States, 19438
- Pfizer Investigational Site
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Virginia
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Richmond, Virginia, United States, 23249
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subjects with clinically significant, recent cardiovascular disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Summarization of safety data in smokers treated with either varenicline or placebo.
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Secondary Outcome Measures
Outcome Measure |
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Information will be collected for the 7 day point prevalence of smoking cessation.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Study Completion
March 1, 2005
Study Registration Dates
First Submitted
August 31, 2005
First Submitted That Met QC Criteria
August 31, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Estimate)
June 4, 2007
Last Update Submitted That Met QC Criteria
June 1, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A3051037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
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University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
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Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
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Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
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University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
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University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
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Yale UniversityCompletedSmoking | Smoking CessationUnited States
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Johns Hopkins UniversityMaryland Department of Health and Mental HygieneCompletedCOach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (C2Q)Smoking | Smoking CessationUnited States
Clinical Trials on varenicline (CP-526,555)
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PfizerCompletedSmoking CessationUnited States
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PfizerCompleted
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PfizerCompletedSmoking CessationUnited States, United Kingdom, Belgium, France, Netherlands
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PfizerCompletedSmoking CessationUnited States
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PfizerCompletedSmoking CessationUnited States
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PfizerCompletedSmoking CessationUnited States, Canada, Norway, Sweden, United Kingdom, Czech Republic, Denmark
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PfizerCompletedSmoking CessationUnited States
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PfizerCompleted
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PfizerCompletedSmoking CessationUnited States
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PfizerCompletedSmoking CessationUnited States, Canada