NCT00143299已完成3 期
A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for 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
- 375
- 试验地点
- 10
- 主要终点
- Summarization of safety data in smokers treated with either varenicline or placebo.
研究概览
简要总结
The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.
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, recent cardiovascular disease.
结局指标
主要结局
Summarization of safety data in smokers treated with either varenicline or placebo.
次要结局
- Information will be collected for the 7 day point prevalence of smoking cessation.
研究者
研究点 (10)
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