Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in patients with PAH. To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.
To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
10 mg once daily
To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.
* Treatment-emergent adverse events (AEs) * AEs leading to premature discontinuation of study drug * Treatment-emergent serious adverse events (SAEs) * Proportion of patients with treatment-emergent ALT and/or AST abnormality (\> 3, \> 5, and \> 8 x ULN) associated or not with total bilirubin \> 2 x ULN. * Proportion of patients with treatment-emergent hemoglobin abnormality (≦ 100 g/L, and ≦ 80 g/L)
Time frame: Baseline to end of treatment visit (around 6 months on average)
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