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

August 29, 2005
June 1, 2007
December 2004
Not Provided
4-week continuous quit rate (CQR) for Weeks 9-12
smoking cessation
Complete list of historical versions of study NCT00139750 on ClinicalTrials.gov 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
safety
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Smoking Cessation
Drug: CP-526,555 (varenicline)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
February 2006
Not Provided

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.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00139750
A3051046
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2007

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