NCT01389856 - Persistent Pulmonary Hypertension of the Newborn | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

December 31, 2013

Study Completion Date

January 31, 2014

Conditions

Persistent Pulmonary Hypertension of the Newborn

Interventions

DRUG

Bosentan

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.

DRUG

Matching placebo

twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube.