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Randomized Open-Label Phase 1/2a Study to Determine the Maximum Tolerated Dose of Intraventricular Sustained Release Nimodipine for Subarachnoid Hemorrhage (NEWTON Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage)

机译：随机开放标签1 / 2a期研究用于确定用于蛛网膜下腔出血的脑室内缓释尼莫地平的最大耐受剂量（NEWTON 尼莫地平微粒可增强恢复同时降低蛛网膜下腔出血后的毒性）

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Background and Purpose—We conducted a randomized, open-label, phase 1/2a, dose-escalation study of intraventricular sustained-release nimodipine (EG-1962) to determine safety, tolerability, pharmacokinetics, and clinical effects in aneurysmal subarachnoid hemorrhage.

机译：背景与目的-我们进行了一项室内开放缓释尼莫地平（EG-1962）的随机，开放标签，1 / 2a期剂量递增研究，以确定安全性，耐受性，药代动力学和动脉瘤性蛛网膜下腔出血的临床疗效。

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期刊名称 Lippincott Williams Wilkins Open Access
作者
Daniel Hänggi; Nima Etminan; Francois Aldrich; Hans Jakob Steiger; Stephan A. Mayer; Michael N. Diringer; Brian L. Hoh; J Mocco; Herbert J. Faleck; R. Loch Macdonald;
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年(卷),期 -1(48),1
年度 -1
页码 145–151
总页数 7
原文格式 PDF
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中图分类
关键词
brain ischemia hypotension nimodipine subarachnoid hemorrhage sustained release formulation;

机译：脑缺血;低血压;尼莫地平;蛛网膜下腔出血;缓释制剂;

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1. Response by Hanggi and Macdonald to Letter Regarding Article, "Randomized, Open-Label, Phase 1/2a Study to Determine the Maximum Tolerated Dose of Intraventricular Sustained Release Nimodipine for Subarachnoid Hemorrhage (NEWTON [Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage])" [J] . Haenggi Daniel, Macdonald R. Loch Stroke: A Journal of Cerebral Circulation . 2017,第4期

机译：Hanggi和Macdonald对文章的回应，“随机，开放标签，期1/2A研究，以确定蛛网膜下腔出血的最大耐受剂量的腔内持续释放尼莫氏脂（Newton [Nimodipine Microgricle，在蛛网膜下腔后降低毒性的同时降低毒性） ]）“
2. Letter by Rustemi Regarding Article, "Randomized, Open-Label, Phase 1/2a Study to Determine the Maximum Tolerated Dose of Intraventricular Sustained Release Nimodipine for Subarachnoid Hemorrhage (NEWTON [Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage])" [J] . Rustemi Oriela Stroke: A Journal of Cerebral Circulation . 2017,第4期

机译：关于物质的字母，“随机，开放标签，期1/2A研究，以确定蛛网膜下腔出血的最大耐受剂量的脑室持续释放尼莫氏脂（Newton [Nimodipine Microplicle，以提高恢复性，同时降低蛛网膜下腔后毒性]）”
3. Clinical Trial Protocol: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults with Aneurysmal Subarachnoid Hemorrhage [NEWTON-2 (Nimodipine Microparticles to Enhance Recovery While Reducing TOxicity After SubarachNoid Hemorrhage)] [J] . Haenggi Daniel, Etminan Nima, Mayer Stephan A., Neurocritical care . 2019,第1期

机译：临床试验方案：第3阶段，多中心，随机，双盲，安慰剂控制，平行群，疗效和安全性研究比较EG-1962与动脉瘤蛛网膜瘤出血的病例中的护理口腔尼莫氏脂（Newton-2）（Nimodipine）微粒以增强恢复，同时减少蛛网膜下腔出血后的毒性）]
4. Local Delivery of Nimodipine by Prolonged-Release Microparticles—Feasibility Effectiveness and Dose-Finding in Experimental Subarachnoid Hemorrhage [O] . Daniel Hänggi, Jason Perrin, Sven Eicker, -1

机译：尼莫地平就地交货的缓释微粒可行性研究实验蛛网膜下腔出血疗效和剂量探索
5. Randomized, open-label, phase 1/2a study to determine the maximum tolerated dose of intraventricular sustained release nimodipine for subarachnoid hemorrhage (NEWTON [Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage]) [O] . Hanggi, Daniel, Etminan, Nima, Aldrich, Francois, 2017

机译：随机，开放标签，1 / 2a期研究，用于确定用于蛛网膜下腔出血的脑室内缓释尼莫地平的最大耐受剂量（NEWTON [尼莫地平微粒可增强恢复，同时降低蛛网膜下腔出血后的毒性]）

Randomized Open-Label Phase 1/2a Study to Determine the Maximum Tolerated Dose of Intraventricular Sustained Release Nimodipine for Subarachnoid Hemorrhage (NEWTON Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage)

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