NCT00741884撤回2 期
A Phase 2, Seven Week, Double-Blind, Placebo Controlled, Randomized, Parallel Group Study To Evaluate The Safety And Efficacy Of Three Doses Of A Controlled Release Formulation Of Varenicline For Smoking Cessation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of varenicline controlled release (CR) tablets in adult smokers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female cigarette smokers between the ages of 18 and 75 years, inclusive, who are motivated to stop smoking.
- •Females of non-childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included.
- •Subjects must have smoked an average of at least 10 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.
- •Subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past 12 months.
- •Subjects having active suicidal ideation or behavior identified at Screen or Baseline.
- •Subjects currently or within the past 12 months requiring treatment for depression. Subjects with current or prior history of panic disorder, anxiety disorder, hostility or aggression disorder, perceptual/thinking disturbances, psychosis, or bipolar disorder.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Varenicline Controlled Release 1.2 mg (Drug)
Arm 2
Experimental
干预措施: Varenicline Controlled Release 1.8 mg (Drug)
Arm 3
Experimental
干预措施: Varenicline Controlled Release 2.4 mg (Drug)
Arm 4
Active Comparator
干预措施: Varenicline Immediate Release 1 mg (Drug)
Arm 5
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed
时间窗: 7 weeks
次要结局
- 7- day point prevalence of non-smoking at week 7(7 days)
- Scores on the Minnesota Nicotine Withdrawal Scale subscales(7 weeks)
- Scores on the Modified Cigarette Evaluation Questionaire subscales(7 weeks)
- PK analysis(7 weeks)
- Safety Assessments: adverse events, C-SSRs, vital signs, body weight(7 weeks)
研究者
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