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

Completed · Phase 3

Conditions studied: Smoking Cessation

In brief

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.

Key facts

Study ID

NCT00143286

Run by

Pfizer

People needed

2000

Starts

2003-04-01

Expected to finish

2005-03-01

Last updated by the study team

2007-06-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subjects with clinically significant cardiovascular disease in the past 6 months.

Where it is running

• Pfizer Investigational Site — Santa Ana, California, United States
• Pfizer Investigational Site — West Palm Beach, Florida, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Mogadore, Ohio, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — Seattle, Washington, United States
• Pfizer Investigational Site — Calgary, Alberta, Canada
• Pfizer Investigational Site — Halifax, Nova Scotia, Canada
• Pfizer Investigational Site — Ottawa, Ontario, Canada
• Pfizer Investigational Site — Toronto, Ontario, Canada
• Pfizer Investigational Site — Cornwall, Prince Edward Island, Canada
• Pfizer Investigational Site — Sherbrooke, Quebec, Canada
• Pfizer Investigational Site — Prague, Czechia
• Pfizer Investigational Site — Hellerup, Copenhagen, Denmark
• Pfizer Investigational Site — Aarhus C, Denmark
• Pfizer Investigational Site — Frederikssund, Denmark
• Pfizer Investigational Site — Bergen, Norway
• Pfizer Investigational Site — Hønefoss, Norway
• Pfizer Investigational Site — Oslo, Norway
• Pfizer Investigational Site — Gothenburg, Sweden
• Pfizer Investigational Site — Helsingborg, Sweden
• Pfizer Investigational Site — Stockholm, Sweden
• Pfizer Investigational Site — London, Surrey, United Kingdom
• Pfizer Investigational Site — London, United Kingdom

Full record on ClinicalTrials.gov

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