NCT00143364已完成3 期
A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban 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
- 1,005
- 试验地点
- 14
- 主要终点
- 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.
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 who have used bupropion (Zyban or Wellbutrin) previously.
结局指标
主要结局
4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
次要结局
- Continuous abstinence Weeks 9-52
- Long-term Quit Rate Week 52
- Continuous abstinence Weeks 9 -24
- 7-day Point Prevalence Abstinence Weeks 12, 24, and 52
- 4-week Point Prevalence Abstinence at Week 52
- Minnesota Nicotine Withdrawal Scale
- Brief Questionnaire of Smoking Urges
- Smoking Effects Inventory
- Change from baseline in bodyweight
研究者
研究点 (14)
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