NCT00150228已完成2 期
A Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) 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
- 300
- 试验地点
- 7
- 主要终点
- 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
研究概览
简要总结
The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051019
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 an average of at least ten cigarettes per day during the past year
- •No period of abstinence greater than three months in the past year
排除标准
- •Subjects with history of clinically significant cardiovascular disease
- •Subjects with uncontrolled hypertension.
结局指标
主要结局
4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
次要结局
- Number of cigarettes smoked per day
- 7-day point prevalence of abstinence at Week 12
- Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale
- Continuous abstinence rate from target quit date to end of treatment (Week 12)
- Rewarding effects of smoking assessed by Smoking Effects Inventory
- weight change from baseline
研究者
研究点 (7)
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