JPRN-jRCT2080223313已完成3 期
A double-blind study to assess the efficacy and safety of clazosentan in reducing cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage treated by surgical clipping
Idorsia Pharmaceuticals Japan Ltd.0 个研究点目标入组 220 人开始时间: 2016年9月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
研究概览
简要总结
The incidence of Morbidity/Mortality events was significantly decreased in the clazosentan 10 mg/h group compared with the placebo group. The incidence of adverse events in the clazosentan 10 mg/h group differed from the placebo group in terms of fluid retention events and anemia, but there were no new safety concerns.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •patients treated by surgical clipping
- •WFNS GradeI - IV
- •Fisher group 3
排除标准
- •Presence of cerebral vasospasm seen prior to the clipping procedure etc.
研究者
相似试验
已完成
3 期
A double-blind study to assess the efficacy and safety of clazosentan in reducing cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage treated by endovascular coilingJPRN-jRCT2080223314Idorsia Pharmaceuticals Japan Ltd.220
已完成
3 期
Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain, Caused by Bleeding Onto the Surface of the BrainAneurysmal Subarachnoid HemorrhageNCT03585270Idorsia Pharmaceuticals Ltd.409
已完成
3 期
Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical ClippingAneurysmal Subarachnoid HemorrhageNCT00558311Idorsia Pharmaceuticals Ltd.1,157
终止
3 期
Clazosentan in Aneurysmal Subarachnoid HemorrhageAneurysmal Subarachnoid HemorrhageNCT00940095Idorsia Pharmaceuticals Ltd.577
已完成
1 期
A Study in Healthy Subjects to Investigate Whether Administration of Clazosentan Can Affect Normal Heart FunctionHealthy SubjectsNCT03657446Idorsia Pharmaceuticals Ltd.36