NCT00594204已完成4 期
A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 593
- 试验地点
- 1
- 主要终点
- Number of Participants With 4-week Continuous Abstinence
研究概览
简要总结
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Current male or female cigarette smokers who are motivated to stop smoking.
- •Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.
排除标准
- •Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
- •Patients currently with depression or diagnosed with depression in past 12 months.
- •Past or present history of psychosis, panic disorder, or bipolar disorder.
研究组 & 干预措施
varenicline
Active Comparator
干预措施: varenicline tartrate (CP-526, 555-18) (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With 4-week Continuous Abstinence
时间窗: Weeks 9 through 12
The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \> 10 parts per milion (ppm) at any of these visits
次要结局
- Number of Participants With Continuous Abstinence(Weeks 9 through 24)
- Number of Participants With Seven-day Point Prevalence of Abstinence(Week 12 and 24)
研究者
研究点 (1)
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