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Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

S

Shandong University

Status

Unknown

Conditions

Persistent Pulmonary Hypertension of the Newborn

Treatments

Drug: Tadalafil Tablets
Drug: Bosentan Tablets
Drug: Sildenafil Tablet

Study type

Observational

Funder types

Other

Identifiers

NCT04379180
2020_PPHN_001

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

Under 28 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: postnatal age ≤ 28 days;
  • Patients have been diagnosed with PPHN;
  • Bosentan, sildenafil and/or tadalafil used as part of regular treatment.
  • Parental written consent

Exclusion criteria

  • Expected survival time less than the treatment cycle;
  • Major congenital malformations;
  • Undergoing surgery within the first week of life;
  • Receiving other systemic trial drug therapy;
  • Other factors that the researcher considers unsuitable for inclusion.

Trial design

500 participants in 1 patient group

Treatment(bosentan, sildenafil and tadalafil)
Treatment:
Drug: Sildenafil Tablet
Drug: Bosentan Tablets
Drug: Tadalafil Tablets

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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