NCT01480336已完成不适用
The Pharmacokinetics and Electrocardiographic Implications of Adjunctive Amiodarone and Ranolazine Therapy in Patients on Implantable Cardioverter Defibrillators: The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Parameter Estimates
研究概览
简要总结
The purpose of this study is to learn if combination therapy with amiodarone and ranolazine (an approved drug for chest pain) can help prevent arrhythmias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an ICD who were on a stable dose of amiodarone for the past 60 days
排除标准
- •Patients with a life expectancy of less than 6 months
- •Patients with moderate or severe hepatic impairment (Child-Pugh Classes B or C) or requiring hemodialysis.
- •Pregnancy or lactation.
- •Treatment with potent CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, indinavir, and saquinavir
- •Treatment with CYP3A inducers, including rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort.
研究组 & 干预措施
Amiodarone with Placebo
Placebo Comparator
干预措施: Amiodarone with Placebo (Drug)
Amiodarone with Ranolazine
Active Comparator
干预措施: Amiodarone Plus Ranolazine (Drug)
结局指标
主要结局
Pharmacokinetic Parameter Estimates
时间窗: 12 hours
Absorption, Peak concentration, time to peak concentration, clearance, area under the curve
次要结局
- Electrocardiogram (ECG)(12 hours)
研究者
研究点 (1)
Loading locations...
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