Clazosentan: Phase III data
Top-line data from the double-blind, international Phase III CONSCIOUS-2 trial in >1,150 patients showed that 5 mg/h IV clazosentan missed the primary endpoint of significantly reducing cerebral vasospasm-related morbidity and all-cause mortality from baseline vs. placebo to within 6 weeks post-aSAH. Specifically, clazosentan led to a non-significant relative risk reduction of 17% on the endpoint vs. placebo (p=0.1). Actelion said it is evaluating the data and will discuss how best to proceed with the ongoing Phase III CONSCIOUS-3 trial of clazosentan in post-aSAH patients who underwent coiling to secure their aneurysm with that study's steering committee. The company also said it will provide an update on the clazosentan development program in its 3Q10 earnings report on Oct. 21. ...