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Actelion is to initiate the phase III programme CONSCIOUS-2 for the endothelin receptor antagonist Pivlaz (Clazosentan).
The Swiss company said that the study was designed to evaluate the safety and efficacy of Pivlaz in reducing vasospasm-related morbidity and all-cause mortality following aneurysmal subarachnoid haemorrhage (aSAH).
In earlier studies, the use of Pivlaz was associated with up to a 65 per cent reduction in vasospasm – a contraction of blood vessels in the brain.
“Vasospasm is a major problem in patients with aneurysmal subarachnoid haemorrhage,” said Neal Kassell MD, Distinguished Professor and Co-Chairman in the Department of Neurosurgery at the University of Virginia and chairman of the CONSCIOUS-2 Steering Committee (Clazosentan to Overcome Neurological iSChemia and Infarct OccUring after Subarachnoid haemorrhage).
“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.”
Each year more than 80,000 people in the EU, US and Japan have an aSAH with a sudden bleeding into the compartment surrounding the brain.
Two out of three patients who suffer an aSAH are at risk of developing vasospasm.
Prevention and treatment options for vasospasm are limited and if left untreated. One in five patients will subsequently suffer permanent disability or death.
In earlier studies, the use of Pivlaz was associated with a significant reduction in the incidence of vasospasm.