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Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

NCT04379180 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2020-05-07

No results posted yet for this study

Summary

The use of bosentan, sildenafil and tadalafil in neonates with persistent pulmonary hypertension (PPHN) depends mostly on the empirical experience of pediatricians. Moreover, the recommended dose of those three drugs in treating PPHN remains controversial. Therefore, our aim is to study the pharmacokinetics and pharmacodynamics of bosentan, sildenafil and tadalafil in neonates of PPHN then dose a tailor-made therapeutic regimen.

Conditions

  • Persistent Pulmonary Hypertension of the Newborn

Interventions

DRUG

Bosentan Tablets

2mg/kg, bid

DRUG

Sildenafil Tablet

1mg/kg, q6h/q8h

DRUG

Tadalafil Tablets

1mg/kg, qd

Sponsors & Collaborators

  • West China Second University Hospital

    collaborator OTHER

  • Shandong University

    lead OTHER

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-26
Primary Completion
2023-02-26
Completion
2023-05-30
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT04379180 on ClinicalTrials.gov