Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
April 11, 2012 updated by: Pfizer
To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg medication for 12 weeks in smokers
Study Overview
Detailed Description
No sampling method will be applied to this study.
Study Type
Observational
Enrollment (Actual)
3719
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy smokers
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy smokers
|
As prescribed by physician in usual clinical practice.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Week 3 through Week 7
|
|
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).
|
Week 7 through Week 11
|
|
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).
|
At least Week 11
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
June 5, 2007
First Submitted That Met QC Criteria
June 5, 2007
First Posted (Estimate)
June 6, 2007
Study Record Updates
Last Update Posted (Estimate)
May 11, 2012
Last Update Submitted That Met QC Criteria
April 11, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A3051083
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.