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Trial record 1 of 1 for:    NCT00483002
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Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets

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ClinicalTrials.gov Identifier: NCT00483002
Recruitment Status : Completed
First Posted : June 6, 2007
Results First Posted : May 11, 2012
Last Update Posted : May 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 5, 2007
First Posted Date June 6, 2007
Results First Submitted Date April 11, 2012
Results First Posted Date May 11, 2012
Last Update Posted Date May 11, 2012
Study Start Date June 2007
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2012)
  • Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7 [ Time Frame: Week 3 through Week 7 ]
    Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).
  • Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11 [ Time Frame: Week 7 through Week 11 ]
    Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).
  • Percentage of Participants With 7-day Point Prevalence for at Least Week 11 [ Time Frame: At least Week 11 ]
    Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00483002 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
Official Title Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
Brief Summary To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg medication for 12 weeks in smokers
Detailed Description No sampling method will be applied to this study.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy smokers
Condition Smoking Cessation
Intervention Drug: varenicline
As prescribed by physician in usual clinical practice.
Other Name: Champix, Chantix, CP-526,555
Study Groups/Cohorts Healthy smokers
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 Completed
Actual Enrollment
 (submitted: March 21, 2012)
3719
Original Enrollment
 (submitted: June 5, 2007)
4500
Actual Study Completion Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects selected for this study are those who would have been prescribed Champix tablets by the physician according to the subject's condition in usual clinical practice.

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00483002
Other Study ID Numbers A3051083
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2012