NCT01356914已完成2 期
Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Safety, Tolerability and Effect on Atrial Fibrillation Burden of BMS-914392 in Patients With Paroxysmal Atrial Fibrillation and Permanent Pacemaker
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Atrial Fibrillation Burden
研究概览
简要总结
The purpose of the study is to determine whether treatment with BMS-914392 is safe, well tolerated and associated with a reduction of atrial fibrillation burden in patients with paroxysmal atrial fibrillation and permanent pacemaker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Paroxysmal atrial fibrillation (AF)
- •Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics.
- •1-50% AF burden on pacemaker interrogation at screening.
- •Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy.
排除标准
- •Persistent or permanent AF.
- •AF Burden <1% or > 50%.
- •Current or history of neurological diseases and mental disorders.
- •Ejection Fraction < 45%.
- •Severe mitral or aortic valve dysfunction.
- •TIA (Transient Ischemic Attack) within last 12 months.
- •Acute coronary syndrome in the last 2 months.
- •Previous AF ablation.
- •Cardioversion in last 3 months.
- •Current kidney or liver disease, or current cancer.
- •History of neurological and mental disorders.
- •Major surgery within 4 weeks of first dose (cardiac surgery within 4 months).
- •Screening lab test results outside of allowed limits per protocol.
- •QTcF > 450 msec.
研究组 & 干预措施
Treatment A: BMS-914392
Experimental
干预措施: BMS-914392 (Drug)
Treatment B: BMS-914392
Experimental
干预措施: BMS-914392 (Drug)
Treatment C: BMS-914392
Experimental
干预措施: BMS-914392 (Drug)
Treatment D: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Atrial Fibrillation Burden
时间窗: On Day 22 of each cross-over period
次要结局
- Number of participants with adverse events and type of adverse events(At Day 22 of each cross-over period)
- Number of Atrial fibrillation (AF) episodes(At Day 1 of each cross-over period)
- Number of AF episodes(At Day 22 of each cross-over period)
- Duration of AF episodes(At Day 22 of each cross-over period)
- Heart Rate(At Day 22 of each cross-over period)
- Severity of AF (SAF) scale score at the end of each study period(At Day 22 of each cross-over period)
- Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)(At Day 22 of each cross-over period)
- BMS-914392 plasma concentrations and exposures during each study period(At Days 1, 8 and 22 of each cross-over period)
研究者
研究点 (1)
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