NCT00282984已完成3 期
A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 714
- 试验地点
- 1
- 主要终点
- Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)
研究概览
简要总结
The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have stable, documented cardiovascular disease (including at least one of the following diagnosed > 2 months prior to the Screening visit - angina, myocardial infarction (MI), revascularization, transient ischemic attack (TIA), and peripheral vascular disease (PVD).
- •Participants that smoke > 10 cigarettes / day.
排除标准
- •Participants with unstable cardiovascular disease
- •Cardiovascular events in the past 2 months
- •Moderate or severe chronic obstructive pulmonary disease (COPD)
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
varenicline
Experimental
干预措施: Varenicline (Drug)
结局指标
主要结局
Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)
时间窗: weeks 9 through 12
Participants considered Responders (4-week CQR \<=10 parts per million \<ppm\>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was \>10 ppm, subject was considered to be Non-Responder at that timepoint.
次要结局
- Number of Responders With Continuous Abstinence (CA) Through Week 52(Week 9 through Week 52)
- Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12(Week 12)
- Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24(Week 24)
- Number of Participants With a 4 Week Point Prevalence of Smoking Cessation(Week 48 through Week 52 (final 4 weeks of non-treatment period [pd]))
- Number of Long-Term Quit Responders(Week 9 through Week 52)
- Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52(Week 52)
- Number of Responders With Continuous Abstinence (CA) Through Week 24(Week 9 through Week 24)
- Cigarettes Smoked Per Day(Day 21)
- Number of Long-Term Quit Responders From Week 9 Through Week 24(Week 9 through Week 24)
研究者
研究点 (1)
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