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Trial record 1 of 1 for:    NCT00143364
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A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00143364
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : June 4, 2007
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 31, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date June 4, 2007
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00143364 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2007)
  • Continuous abstinence Weeks 9-52
  • Long-term Quit Rate Week 52
  • Continuous abstinence Weeks 9 -24
  • 7-day Point Prevalence Abstinence Weeks 12, 24, and 52
  • 4-week Point Prevalence Abstinence at Week 52
  • Minnesota Nicotine Withdrawal Scale
  • Brief Questionnaire of Smoking Urges
  • Smoking Effects Inventory
  • Change from baseline in bodyweight
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
Continuous abstinence rate weeks 9-52 Long-term quit rate week 52 Continuous abstinence 9 -24 7 day point prevalence week 12, 24, and 52 Results of Minnesota Nicotine Withdrawal Scale Brief Questionnaire of Smoking Urges Smoking Effects Inventory
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation
Official Title  ICMJE A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation
Brief Summary The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE Drug: varenicline (CP-526,555)
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 31, 2005)
1005
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

  • Subjects who have used bupropion (Zyban or Wellbutrin) previously.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143364
Other Study ID Numbers  ICMJE A3051036
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 Center Pfizer
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