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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.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139750
First received: August 29, 2005
Last updated: June 1, 2007
Last verified: June 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier: NCT00139750

Locations
Japan
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer