NCT00483002 - Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets | Crick

Overview

To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg medication for 12 weeks in smokers

No sampling method will be applied to this study.

Study Type

OBSERVATIONAL

Enrollment

3,719

Conditions

Smoking Cessation

Interventions

vareniclineDRUG

As prescribed by physician in usual clinical practice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Week 3 through Week 7

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

Time frame: Week 7 through Week 11

Percentage of Participants With 7-day Point Prevalence for 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).

Time frame: At least Week 11