Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 31, 2005
Last updated: June 1, 2007
Last verified: June 2007

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 Intervention Phase
Smoking Cessation
Drug: varenicline (CP-526,555)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Continuous abstinence Weeks 13 -24.

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

Estimated Enrollment: 2000
Study Start Date: April 2003
Study Completion Date: March 2005

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00143286

  Show 24 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00143286     History of Changes
Other Study ID Numbers: A3051035
Study First Received: August 31, 2005
Last Updated: June 1, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 27, 2014