Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 3,719
- 主要终点
- Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7
研究概览
简要总结
To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg medication for 12 weeks in smokers
详细描述
No sampling method will be applied to this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Healthy smokers
干预措施: varenicline (Drug)
结局指标
主要结局
Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点