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news.Actelion has announced the initiation of the Phase III program, Conscious-2, for the endothelin receptor antagonist Pivlaz. The study is designed to evaluate the safety and efficacy of Pivlaz in reducing vasospasm-related morbidity and all-cause mortality following aneurysmal subarachnoid hemorrhage.
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Conscious-2 is a global study, and will include a minimum of 765 patients from more than 100 centers, randomized 2:1 to receive either 5mg/h of Pivlaz (clazosentan) or placebo. Conscious-2 will subsequently measure the clinical benefits of Pivlaz through the primary endpoint of vasospasm-related morbidity and all-cause mortality which includes neurological deterioration, new brain infarcts, introduction of vasospasm rescue therapy or death from any cause. The Conscious-2 trial will also investigate the effect of Pivlaz on the extended Glasgow outcomes scale (GOSE) at three month as a secondary endpoint.
In earlier studies, the use of Pivlaz was associated with up to 65% reduction in vasospasm, a contraction of blood vessels in the brain.
Neal Kassell, chairman of the Conscious-2 Steering Committee (Clazosentan to overcome neurological iSChemia and Infarct occUrring after subarachnoid hemorrhage), said: “Vasospasm is a major problem in patients with aneurysmal subarachnoid hemorrhage. Vasospasm is both unpredictable and the leading treatable cause of disability and death. A reduction in the occurrence of vasospasm is expected to result in measurable clinical benefit. The Conscious-2 trial is specifically designed to demonstrate this benefit.”