NCT00371813已完成3 期
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate 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
- 334
- 试验地点
- 15
- 主要终点
- To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
研究概览
简要总结
To investigate safety and efficacy of varenicline tartrate in helping people quit smoking
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
- •Current cigarette smokers between the ages of 18 and 75 years, who are motivated to stop smoking
排除标准
- •Patients currently suffering from depression, or have been diagnosed with depression in the last 12 months, or subjects with past or present history of psychosis, panic disorder, or bipolar disorder
- •Any subject with known severe chronic obstructive pulmonary disease (COPD)
结局指标
主要结局
To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
次要结局
- To gather safety data for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by 12 weeks of non-treatment follow-up.
研究者
研究点 (15)
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