Champix Tablets Special Investigation -Retrospective Survey For Subjects Who Have Been Retreated With Champix.-(Regulatory Post Marketing Commitment Plan).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
- 主要终点
- Number of Responders to Varenicline Treatment
研究概览
简要总结
The purpose of this study is to collect the efficacy and safety information in subjects who have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for their appropriate use in daily practice and are participants for varenicline Drug Use Investigation protocol A3051109 ((NCT# NCT00772941).
详细描述
The subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female subjects intend to quit tobacco use who are prescribed varenicline (Champix®) by their Physicians
- •Subjects who are prescribed varenicline (Champix®) for the second time within 52 weeks of initial treatment.
排除标准
- •Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109.
研究组 & 干预措施
varenicline (Champix®)
Subjects who have been retreated with varenicline within 52 weeks and have been enrolled to varenicline protocol A3051109.
干预措施: varenicline (Drug)
结局指标
主要结局
Number of Responders to Varenicline Treatment
时间窗: 24 weeks
Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period.
Number of Participants With Treatment-Related Adverse Events (AEs)
时间窗: 24 weeks
An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.
次要结局
- Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert(24 weeks)
- Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)(24 weeks)
- Number of Participants With Risk Factors Likely to Affect the Proportion of Responders(24 weeks)