Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: varenicline

• Registration Number: NCT00483002
• Lead Sponsor: Pfizer

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-05
• Study First Submitted QC: 2007-06-05
• Study First Posted: 2007-06-06
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-04
• Results First Submitted: 2012-04-11
• Results First Submitted QC: 2012-04-11
• Last Update Submitted: 2012-04-11
• Results First Posted: 2012-05-11
• Last Update Posted: 2012-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3719

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy smokers	varenicline	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7	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	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	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).