clazosentan and Cerebral-Hemorrhage

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.

Topics: Animals; Cerebral Hemorrhage; Dioxanes; Drug Tolerance; Drug-Related Side Effects and Adverse Reactions; Endothelin Receptor Antagonists; Humans; Pyridines; Pyrimidines; Receptors, Endothelin; Sulfonamides; Tetrazoles; Vasospasm, Intracranial