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

NCT00139750

Last updated date
Study Location
Pfizer Investigational Site
Noda, Chiba, , Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects who have used a nicotine replacement product within 30 days of the study
screening visit or intend to use it during the study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation
Official Title  ICMJE A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE Drug: CP-526,555 (varenicline)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 30, 2005)
600
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00139750
Other Study ID Numbers  ICMJE A3051046
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2007

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