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12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 29, 2005
Last updated: June 1, 2007
Last verified: June 2007

August 29, 2005
June 1, 2007
December 2004
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4-week continuous quit rate (CQR) for Weeks 9-12
smoking cessation
Complete list of historical versions of study NCT00139750 on Archive Site
  • Continuous abstinence for Weeks 9-52 and Weeks 9-24
  • Long-term quit rate at Week 52
  • 4-week CQR for Weeks 4-7
  • 7-day point prevalence of asbtinence Weeks 12, Week 24, and Week 52
  • Continuous abstinence from TQD (Week 1) through Week 12
  • Weekly average number of cigarettes smoked per day for Weeks 1-12
  • Evaluation of withdrawal symptoms by the Minnesota Nicotine Withdrawal Scale
  • Evaluation of smoking satisfaction by the Smoking Effects Inventory
  • Evaluation of urge to smoke by the Brief Questionnaire of Smoking Urges
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12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation
A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Smoking Cessation
Drug: CP-526,555 (varenicline)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2006
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Inclusion Criteria:

  • Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day

Exclusion Criteria:

  • Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Pfizer Call Center Pfizer
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP