NCT01574703已完成4 期
A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders
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
- 4,595
- 试验地点
- 131
- 主要终点
- Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
研究概览
简要总结
Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.
详细描述
This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123. This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
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
- 是
入选标准
- •Subjects will be eligible if they were randomized to study A3051123.
排除标准
- •Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.
研究组 & 干预措施
placebo
Experimental
干预措施: placebo (Drug)
varenicline
Experimental
干预措施: varenicline tartrate (Drug)
bupropion
Experimental
干预措施: bupropion hydrochloride (Drug)
Nicotine Replacement Therapy Patch
Experimental
干预措施: Nicotine Replacement Therapy Patch (Drug)
结局指标
主要结局
Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
时间窗: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.
次要结局
- Time to MACE Until the End of Study NCT01574703.(Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).)
- Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.(Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.)
- Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.(Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
- Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.(Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.)
- Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.(Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
- Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.(Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.)
- Incidence of MACE Assessed Until End of Study NCT01574703.(Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).)
- Incidence of MACE+ Assessed Until End of Study NCT01574703.(Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).)
研究者
研究点 (131)
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