期刊
EXPERT OPINION ON INVESTIGATIONAL DRUGS
卷 17, 期 11, 页码 1761-1767出版社
TAYLOR & FRANCIS LTD
DOI: 10.1517/13543784.17.11.1761
关键词
clazosentan; endothelin; subarachnoid hemorrhage; vasospasm
Clazosentan (Ro 61-1790, VML-588 or AXV-034) is under study in clinical trials for the treatment of patients with aneurysmal subarachnoid hemorrhage (SAH) by Actelion Pharmaceuticals. It is a synthetic endothelin (ET) A receptor antagonist that decreases and reverses cerebral vasospasm after experimental SAH. Remarkable dose-dependent effects were observed on angiographic vasospasm in the CONSCIOUS-1 human clinical trial, supporting proceeding with a Phase III clinical trial. This study (CONSCIOUS-2) will enroll approximately 765 patients randomized 2:1 to clazosentan 5 mg/h intravenously or placebo. All patients will undergo neurosurgical aneurysm clipping and outcome will be assessed primarily based on mortality and vasospasm-related morbidity.
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