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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
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.

Condition Intervention Phase
Smoking Cessation Drug: CP-526,555 (varenicline) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 4-week continuous quit rate (CQR) for Weeks 9-12

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 600
Study Start Date: December 2004
Study Completion Date: February 2006

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00139750

Pfizer Investigational Site
Noda, Chiba, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Beppu-shi, Oita-ken, Japan
Pfizer Investigational Site
Toyonaka, Osaka, Japan
Pfizer Investigational Site
Tosu, Saga, Japan
Pfizer Investigational Site
Hamamatsu, Shizuoka, Japan
Pfizer Investigational Site
Edogawa-ku, Tokyo, Japan
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Pfizer Investigational Site
Musashino, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa-ku, Tokyo, Japan
Pfizer Investigational Site
Toshima-ku, Tokyo, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Ohita, Japan
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00139750     History of Changes
Other Study ID Numbers: A3051046
Study First Received: August 29, 2005
Last Updated: June 1, 2007

Additional relevant MeSH terms:
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on August 18, 2017