Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension children pediatric bosentan
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 64
Healthy volunteers: no

Brief summary:
The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) \<12 years of age.

Detailed description:

Arms:
arm 1: 2 mg/kg bosentan administered three times a day (morning, afternoon, evening) for a planned duration of 24 weeks arm 2: 2 mg/kg bosentan administered twice daily (morning and evening) for a planned duration of 24 weeks

Interventions: intervention 1: bosentan
Intervention descriptions: intervention 1: 32 mg quadrisected dispersible tablet. The dosage of bosentan (2 mg/Kg) was adjusted according to the patient's body weight at initiation of the study treatment. Dosage readjustment was permitted after 12 weeks of treatment.

Protocol document: