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A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00143286
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : June 4, 2007
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: varenicline (CP-526,555) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Study Start Date : April 2003
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Continuous abstinence Weeks 13 -24.

Secondary Outcome Measures :
  1. Continuous abstinence Weeks 13-52
  2. Long term quit rate at Week 52
  3. 7-day Point Prevalence of abstinence at Weeks 24, 52
  4. 4-week Point Prevalence of abstinence at Week 52
  5. Time to first cigarette post randomization

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 cardiovascular disease in the past 6 months.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143286


Locations
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United States, California
Pfizer Investigational Site
Santa Ana, California, United States
United States, Florida
Pfizer Investigational Site
West Palm Beach, Florida, United States
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States
United States, Ohio
Pfizer Investigational Site
Mogadore, Ohio, United States
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Pfizer Investigational Site
Ottawa, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Canada, Prince Edward Island
Pfizer Investigational Site
Cornwall, Prince Edward Island, Canada
Canada, Quebec
Pfizer Investigational Site
Sherbrooke, Quebec, Canada
Czech Republic
Pfizer Investigational Site
Prague 2, Czech Republic
Denmark
Pfizer Investigational Site
Hellerup, Copenhagen, Denmark
Pfizer Investigational Site
Aarhus C, Denmark
Pfizer Investigational Site
Frederikssund, Denmark
Norway
Pfizer Investigational Site
Bergen, Norway
Pfizer Investigational Site
Honefoss, Norway
Pfizer Investigational Site
Oslo, Norway
Sweden
Pfizer Investigational Site
Göteborg, Sweden
Pfizer Investigational Site
Helsingborg, Sweden
Pfizer Investigational Site
Stockholm, Sweden
United Kingdom
Pfizer Investigational Site
London, Surrey, United Kingdom
Pfizer Investigational Site
London, United Kingdom
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00143286    
Other Study ID Numbers: A3051035
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: June 4, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs