NCT00143325已完成3 期
An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch 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
- 730
- 试验地点
- 21
- 主要终点
- Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
研究概览
简要总结
Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch 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 15 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 cardiovascular disease in the past 6 months.
结局指标
主要结局
Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
次要结局
- Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52
- 7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52
- 4-week Point Prevalence of abstinence at Week 52
- Long-Term Quit Rate at Weeks 24 and 52
- Minnesota Nicotine Withdrawal Scale
- Smoking Effects Inventory
研究者
研究点 (21)
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