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Persistent Pulmonary Hypertension of the Newborn

NCT01389856 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-02-04

Study results available
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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

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.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Hours
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-12-31
Completion
2014-01-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01389856 on ClinicalTrials.gov