NCT00504842终止1 期
A Phase 1-2, Randomized, Placebo-Controlled, Single-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Activity of Ascending Single Doses of MRX-801 With Continuous Ultrasound Administration in Subjects With Acute Ischemic Stroke Receiving Treatment With Intravenous Tissue Plasminogen Activator
ImaRx Therapeutics14 个研究点 分布在 2 个国家目标入组 72 人开始时间: 2006年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 72
- 试验地点
- 14
- 主要终点
- Incidence of symptomatic intracranial hemorrhage
研究概览
简要总结
This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
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
- Single
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
- •Acute ischemic stroke
- •Occlusion demonstrated by transcranial Doppler ultrasound
- •Eligible for tPA
排除标准
- •Right to left cardiac shunt
- •Moderate to severe COPD
- •Uncontrolled hypertension
结局指标
主要结局
Incidence of symptomatic intracranial hemorrhage
时间窗: 36 hours
次要结局
- Rate of recanalization of occluded artery(120 minutes)
- Independent outcome (modified Rankin Scale 0-2)(90 days)
研究者
研究点 (14)
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