A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 659
- 试验地点
- 1
- 主要终点
- Percentage of Participants With 4-week Continuous Abstinence (CA)
研究概览
简要总结
The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •18 to 75 yrs old
- •Motivated to stop smoking
- •Smoke at least 10 cigarettes/day
排除标准
- •Active psychiatric disease
- •Severe or unstable cardiovascular or pulmonary disease
- •Current or recent treatment to stop smoking
- •Previous use of varenicline
研究组 & 干预措施
placebo
干预措施: placebo (Drug)
varenicline
干预措施: varenicline (Drug)
结局指标
主要结局
Percentage of Participants With 4-week Continuous Abstinence (CA)
时间窗: Week 9 through Week 12
The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \>10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO \>10 ppm.
次要结局
- Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)(Week 12 and Week 24)
- Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24(Week 9 through Week 24)
- Percentage of Participants With Long Term Quit Through Week 24(Week 9 through Week 24)
- Percentage of Participants With 4-week Point Prevalence of Nonsmoking(Week 24)