A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking

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NCT00635401

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Study Location
Pfizer Investigational Site
Chuo-ku Fukuoka, Fukuoka, , Japan
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking
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

- Japanese smokers motivated to quit smoking

- No period without smoking of more than 3 months

- Smoked an average of at least 10 cigarettes/day in the past year

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


- Subjects who have used nicotine replacement therapy within 1 month of the study
screening visit


- Subjects intending to use nicotine replacement therapy or other smoking cessation
treatments during the study

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking
Official Title  ICMJE A Multicenter, Open-Label Study Exploring the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking
Brief Summary The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers. Safety is evaluated by adverse events, laboratory tests, and other safety tests.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Smoking
Intervention  ICMJE Drug: Varenicline
0.5 mg BID for 7 weeks
Other Name: Chantix, Champix, CP-526,555
Study Arms  ICMJE Experimental: 0.5 mg BID
Intervention: Drug: Varenicline
Publications * Not Provided

*   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
Actual Enrollment  ICMJE
 (submitted: March 5, 2008)		30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese smokers motivated to quit smoking
  • No period without smoking of more than 3 months
  • Smoked an average of at least 10 cigarettes/day in the past year

Exclusion Criteria:

  • Subjects who have used nicotine replacement therapy within 1 month of the study screening visit
  • Subjects intending to use nicotine replacement therapy or other smoking cessation treatments 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 NCT00635401
Other Study ID Numbers  ICMJE A3051043
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2008

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