NCT00143286已完成3 期
A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
适应症
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
- 2,000
- 试验地点
- 23
- 主要终点
- Continuous abstinence Weeks 13 -24.
研究概览
简要总结
The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.
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
- Double
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
- •Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
排除标准
- •Subjects with clinically significant cardiovascular disease in the past 6 months.
结局指标
主要结局
Continuous abstinence Weeks 13 -24.
次要结局
- Continuous abstinence Weeks 13-52
- Long term quit rate at Week 52
- 7-day Point Prevalence of abstinence at Weeks 24, 52
- 4-week Point Prevalence of abstinence at Week 52
- Time to first cigarette post randomization
研究者
研究点 (23)
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