"VIBRATIONS": Varenicline In Patients Ambitioned To Terminate Smoking - A Non-Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,177
- 主要终点
- Percentage of Participants Who Abstained From Smoking at Week 12
研究概览
简要总结
The aim of this study is to determine the success rates for stopping smoking with varenicline in Germany. The main measure of success will be continuous abstinence from smoking (not a single puff) in the last week of the standard 12 week treatment period. Additional information will be gathered regarding prescribing practices in Germany, smoking history, reasons why smokers quit smoking and re-start smoking, smoking related illnesses and the tolerability of varenicline.
详细描述
Sampling Method Details: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
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
- •Legal adult age
- •Regular smoker, with main tobacco product smoked being cigarettes, and willing and motivated to stop smoking
- •Evidence of a personally signed and dated Informed Consent document.
排除标准
- •Any subjects considered unsuitable according to the Summary of product characteristics (SmPC)
研究组 & 干预措施
Single group prospective treatment cohort (varenicline)
干预措施: Varenicline (Drug)
结局指标
主要结局
Percentage of Participants Who Abstained From Smoking at Week 12
时间窗: Week 12
The use of nicotine was recorded using Nicotine Use Inventory (NUI) to determine the participants who abstained from smoking for the previous 7 days. A responder for the 7-day point prevalence was defined as those with 'no' answers to the following two questions: Did the participant smoke any cigarettes (even a puff) in the last 7 days; and did participant use any other tobacco products (example pipe, cigars, snuff, chewing tobacco) in the last 7 days.
次要结局
- Level of Nicotine Dependence Measured by the Fagerstrom Test(Baseline)