NCT02059785暂停2 期
Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke---Randomized, Double-blind, Placebo-controlled, Multicenter Study
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days
研究概览
简要总结
This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study. Chinese subjects with Ischemic Stroke.
详细描述
Subjects will randomly enter into one of two groups,the period of treatment is 14 days,follow-up to the 90th days.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35-75 hospitalized patients
- •Patients with acute stroke ≤24h
- •NIHSS score 6-20 at time of enrollment , the score ≥2 of item 5 and/or 6
- •For the first time or always without obvious sequelae of stroke disease(mRS≤1）
- •Informed consent
排除标准
- •The disease such as Acute intracerebral hemorrhage,tumor and encephalitis which cause similar symptoms
- •Patient with NIHSS level of consciousness score≥2 or dementia,or other patients who the investigator think that don't fit into the study
- •Symptoms of disease rapidly improving during the randomized
- •Severe hypertension(SBP > 200 mmHg or DBP >110 mmHg)
- •Inadequate liver function(AST or ALT greater than 2 times the upper limit of normal values);Renal impairment (Creatinine clearance <60ml/min）
- •Severe system or viscera organic disease
- •Have used other neuroprotectant or other experimental drugs
- •Patient who are unlikely to complete the study that due to a severe clinical condition
- •Pregnant or breast-feeding
- •Participation in a previous clinical study within 30 days
- •Meets all other exclusion criteria
研究组 & 干预措施
Pinocembrin for Injection
Experimental
40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day
干预措施: Pinocembrin for Injection (Drug)
placebo
Placebo Comparator
60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day
干预措施: Pinocembrin for Injection (Drug)
结局指标
主要结局
To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days
时间窗: 90 days
次要结局
- To compare treatment arms in terms of change from baseline to endpoint in NIHSS score.(90 days)
研究者
研究点 (1)
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