NCT00137332终止2 期
A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction
Wyeth is now a wholly owned subsidiary of Pfizer33 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 90
- 试验地点
- 33
- 主要终点
- The measure to determine the effect of the intervention will be whether abnormally fast heart rhythm can be induced after test drug is administered.
研究概览
简要总结
The purpose of this study is to learn the effects of a test drug on heart rhythms, which may become life-threatening if left untreated, and to provide data to see if the drug is well tolerated and safe.
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
- Double
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
- •Patients with or without ICDs (implantable cardioverter defibrillators)
- •Patients undergoing an electrophysiology study for evaluation of ventricular rhythm
- •Patients with a history of heart disease
排除标准
- •Patients with uncontrolled blood pressure
- •Patients with certain cardiac risk factors
- •Patients with significant kidney or liver problems
结局指标
主要结局
The measure to determine the effect of the intervention will be whether abnormally fast heart rhythm can be induced after test drug is administered.
次要结局
- This study takes place within 24 hours, and looks at whether the test article makes a difference in inducing the abnormally fast heart rhythm during a 24 hour observational period.
研究者
研究点 (33)
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