Conditions: Pulmonary Arterial Hypertension
Keywords: pediatric pulmonary arterial hypertension bosentan Tracleer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 58
Healthy volunteers: no

Brief summary:
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).

Detailed description:

Arms:
arm 1: Patients who received 2 mg/kg bosentan twcie daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study arm 2: Patients who received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study

Interventions: intervention 1: Bosentan
Intervention descriptions: intervention 1: Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day

Protocol document: