NCT00150241已完成2 期
A Seven-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Three Doses of CP-526,555 ( 0.3 mg QD, 1 mg QD, and 1 mg BID ) in Comparison With Zyban in Smoking Cessation
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 625
- 试验地点
- 7
- 主要终点
- The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
研究概览
简要总结
The purpose of the study is to measure the safety and efficacy of three doses of varenicline 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have smoked on average of at least ten cigarettes per day during the past year
- •Subjects must have no period of abstinence greater than three months in the past year
排除标准
- •Subjects with any history of cardiovascular disease
- •Myocardial infarction
- •Significant arrhythmias
- •Poorly controlled hypertension
结局指标
主要结局
The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
次要结局
- 7-day Point Prevalence of abstinence Week 52
- Fixed window 4-week CQR, Weeks 3-6, 4-7
- Continuous abstinence from Target Quit Date to Weeks 12, 24, and 52
- Number of cigarettes smoked per day
- Minnesota Nicotine Withdrawal Scale
- Smoking Effects Inventory
- Brief Questionnaire of Smoking Urge
研究者
研究点 (7)
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