EUCTR2016-001005-16-NL进行中（未招募）1 期
Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event. International, multi-centre, randomized, double-blind placebo-controlled phase II study. - RESTORE BRAIN study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 585
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Patients aged between 18 and 85 years (both inclusive)
- •- Acute ischemic stroke that occurred between 72 hours (3 days) and 192 hours (8 days) (both inclusive) before inclusion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 145
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 435
排除标准
- •- Any non-selection criteria, which could have occurred after the selection visit
- •- Positive urinary or blood pregnancy test (for female patients of child bearing potential)
- •- Any clinically significant findings from the local laboratory test likely to interfere with the ability to participate in the study and / or with the study outcome
- •- Severe renal impairment
- •- Severe hepatic impairment or liver enzymes abnormalities found in the local laboratory test
- •- Stroke due to cerebral venous thrombosis
- •- Brain MRI showing a severe microangiopathy
- •- Brain imaging showing an acute haemorrhagic stroke or a symptomatic haemorrhagic transformation of the brain infarct
- •- Qualifying ischemic cerebral event older than 192 hours at inclusion
- •- Any clinically relevant abnormalities detected during the examinations likely to interfere with study procedures or study outcome,
- •- Repeated prolongation of ECG QTcF
- •- Patient refusing to attend study visits or to take part in the study
研究者
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