NCT04379180

Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

Population Pharmacokinetics and Dosage Individualization of Bosentan, Sildenafil and Tadalafil in Persistent Pulmonary Hypertension of the Newborn

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Bosentan Tablets	2mg/kg, bid
DRUG	Sildenafil Tablet	1mg/kg, q6h/q8h
DRUG	Tadalafil Tablets	1mg/kg, qd

Timeline

• Start date: 2020-04-26
• Primary completion: 2023-02-26
• Completion: 2023-05-30
• First posted: 2020-05-07
• Last updated: 2020-05-07

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study