A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 498
- 试验地点
- 37
- 主要终点
- Continuous Abstinence Rate (CAR) From Week 9 Through Week 12
研究概览
简要总结
The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smokers aged 18 years or above and wanting to stop smoking
- •Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
- •Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
- •The last attempt to stop smoking must be at least 3 months before entering the study
排除标准
- •Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
- •Individuals who have previously participated in clinical trials of varenicline
- •Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Varenicline
干预措施: Varenicline (Drug)
结局指标
主要结局
Continuous Abstinence Rate (CAR) From Week 9 Through Week 12
时间窗: Week 9 through Week 12
The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)\> 10ppm at any visits during this time frame.
次要结局
- CAR From Week 9 Through Week 52(Week 9 through Week 52)
- CAR From Week 9 Through Week 24(Week 9 through Week 24)
- 7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52(Weeks 12, 24 and 52)