NCT01389856

Persistent Pulmonary Hypertension of the Newborn

Multicenter, Double-blind, Placebo-controlled, Randomized, Prospective Study of Bosentan as Adjunctive Therapy to Inhaled Nitric Oxide in the Management of Persistent Pulmonary Hypertension of the Newborn (PPHN)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 12 Hours – 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Pulmonary Hypertension of the Newborn

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2011-07-08
• Last updated: 2025-02-04
• Results posted: 2015-03-23