Conditions: Persistent Pulmonary Hypertension of the Newborn
Keywords: Persistent pulmonary hypertension, newborn PPHN
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 23
Healthy volunteers: no

Brief summary:
The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.

Detailed description:

Arms:
arm 1: Bosentan arm 2: Matching placebo

Interventions: intervention 1: Bosentan intervention 2: Matching placebo
Intervention descriptions: intervention 1: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube. intervention 2: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube.

Protocol document: