Post-Marketing Surveillance Study To Observe The Safety And Effectiveness Of Varenicline (Champix) Tablets In Smoking Cessation Among Filipino Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 330
- 主要终点
- Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4
研究概览
简要总结
The primary objective of this Post-Marketing Study is to monitor the safety of a novel smoking cessation drug Varenicline (Champix™) 0.5 mg and 1 mg tablets as used in clinical practice for 12 weeks among Filipino smokers.
The secondary objective is to further evaluate the effectiveness of Varenicline (Champix™) as an aid in smoking cessation based on the 7-day point prevalence of smoking cessation
详细描述
The study will enroll smoking patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Smoking adults aged ≥ 18 years intending to quit tobacco use who are prescribed Varenicline (Champix™) by their Physicians and those who are prescribed with Varenicline (Champix™) for the first time.
排除标准
- •Subjects in whom varenicline (Champix™) may be taken in a manner that is not according to the approved local product document.
- •Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception
- •Subjects with known hypersensitivity to varenicline.
研究组 & 干预措施
Open-label
干预措施: Varenicline (Drug)
结局指标
主要结局
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4
时间窗: Week 4
Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: "In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?". Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8
时间窗: Week 8
Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: "In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?". Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12
时间窗: Week 12
Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: "In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?". Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.
次要结局
未报告次要终点