NCT00075959已完成2 期
CHANT (Cerebral Hemorrhage And NXY Treatment) A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter, Phase IIb Study to Assess the Safety and Tolerability of Intravenous Infusion of NXY-059 in Adult Patients With Acute Intracerebral Hemorrhage (ICH)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 600
- 试验地点
- 64
- 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 is safe in patients with an acute stroke caused by bleeding in the central nervous system. The primary objective was to assess the safety and tolerability of NXY-059 compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Intracerebral Hemorrhage as the cause of stroke symptoms
- •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 7 days.
- •Meets all other exclusion criteria
结局指标
主要结局
Global disability on modified Rankin scale at 90 days
次要结局
- NIH stroke scale
- Barthel Index
- Stroke Impact Scale
研究者
研究点 (64)
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