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news.Actelion has initiated a Phase III study for its highly potent, tissue-targeting endothelin receptor antagonist Actelion-1 to evaluate the clinical benefit of Actelion-1 through the primary endpoint of morbidity and all-cause mortality in patients with symptomatic pulmonary arterial hypertension.
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The study is designed to evaluate the safety and efficacy of Actelion-1 in delaying disease progression and mortality in patients with pulmonary arterial hypertension (PAH). The SERAPHIN study is a global study and will enroll more than 500 patients from at least 180 centers, randomized 1:1:1 to receive two different doses of Actelion-1 (3mg and 10mg once daily) or placebo. The centers represent over 40 countries in North and South America, Europe, Asia Pacific and Africa.
Jean-Paul Clozel, CEO of Actelion, said: “Actelion and Tracleer have revolutionized PAH therapy. A large number of supportive studies in many PAH sub-populations, together with a first-in-class educational marketing approach, have made Tracleer the cornerstone of therapy in PAH.”