NCT00119626已完成3 期
SAINT I (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,700
- 试验地点
- 2
- 主要终点
- Global disability on modified Rankin scale at 90 days.
研究概览
简要总结
This study will determine if NXY-059 will reduce functional disability from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strength and coordination.
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
- •Males and females
- •Acute ischemic stroke with limb weakness, onset of symptoms within 6 hours
- •Full functional independence prior to the present stroke
排除标准
- •Unconsciousness
- •Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition
- •Severe illness with life expectancy less than 6 months
- •Known severe kidney disorder
- •Current known alcohol or illicit drug abuse or dependence
- •Pregnant or breast-feeding
- •Treatment with acetazolamide and methotrexate is not permitted during the infusion
- •Participation in a previous clinical study within 30 days
结局指标
主要结局
Global disability on modified Rankin scale at 90 days.
次要结局
- NIH stroke scale (termed "co-primary" in study protocol), Barthel Index, Stroke Impact Scale, EQ-5D all at 90 days, Safety outcomes.
研究者
研究点 (2)
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