Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension
Completed
Actelion
Phase 3
2008-05-01
The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two
different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with
symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992)
prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk
profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
Completed
Actelion
Phase 3
2008-10-17
The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055
302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in
patients with symptomatic PAH.
Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study
Completed
Actelion
Phase 2
2009-05-01
The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan)
10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study
objective is to demonstrate that macitentan positively affects the forced vital capacity
(FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF).
The secondary objectives are to evaluate the effect of macitentan on the time to disease
worsening or death in patients with IPF, and to evaluate the benefit/risk profile of
macitentan in the treatment of patients with IPF.
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