Homoarginine Supplementation in Patients After Stroke
赞助:
Universitätsklinikum Hamburg-Eppendorf
合作者:
信息的提供 (责任方):
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追踪信息 | |||
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首次提交日期 ICMJE | July 18, 2018 | ||
首次发布日期e ICMJE | October 2, 2018 | ||
最后更新发布日期 | October 2, 2018 | ||
预计研究开始日期 ICMJE | August 22, 2018 | ||
预计主要完成日期 | December 2022 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Homoarginine serum concentration[ Time Frame: six month ] Normalization of homoarginine serum concentration to levels >2.1 umol/L. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Homoarginine Supplementation in Patients After Stroke | ||
正式标题 ICMJE | Homoarginine in Stroke (HiS) Study | ||
简要概况 | This study represents a follow-up of the previous study "Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects" (NCT02675660). This study will evaluate the applicability of an oral formulation of L-homoarginine to normalize homoarginine blood levels in patients with acute ischemic stroke. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: randomized double-blind placebo controlled 盲法: Interventional 盲法描述: 主要目的: Basic Science |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
500 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | August 2023 | ||
预计主要完成日期 | December 2022 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - ischemic stroke (CT or MRI) - serum homoarginine = 2.1 umol/L - signed informed consent Exclusion Criteria: - no acute stroke - serum homoarginine > 2.1 umol/L - heart failure (NYHA > 1) - chronic kidney disease (GFR <60 mL/min) - not competent - pregnancy, lactation - no or withdrawn signed informed consent | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Germany | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | Universitätsklinikum Hamburg-Eppendorf | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | |||
验证日期 | September 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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