Actelion: CONSCIOUS-2 study with clazosentan does not meet primary endpoint

28-Sep-2010 - Switzerland

Actelion Ltd announced the initial results of CONSCIOUS-2 a clinical study evaluating the safety and efficacy of clazosentan in reducing vasospasm-related morbidity and all-cause mortality in clipped patients following aneurysmal subarachnoid hemorrhage (aSAH).

The primary endpoint showed a non-significant relative risk reduction of 17 percent in favor of clazosentan (p=0.1). The safety profile of clazosentan in CONSCIOUS-2 was comparable to previous studies with the compound in this disease.

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "These are, of course, disappointing results. Having embarked upon such a complex study, both in terms of design and execution, I must commend the exceptional efforts of all involved delivering a high-quality study."

Jean-Paul Clozel continued: "Actelion will continue to focus on growing its existing business. With four marketed products, Actelion is generating the necessary revenues to continue to invest appropriately in clinical studies for our more than 10 development compounds."

In regards to the ongoing CONSCIOUS-3 study in patients with aSAH that underwent coiling to secure their aneurysm, Actelion will discuss the appropriate course of action with the Steering Committee.

https://www.bionity.com/en/news/123389/actelion-conscious-2-study-with-clazosentan-does-not-meet-primary-endpoint.html