A study to assess the efficacy, safety, pharmacokinetics, and related polymorphism of medicines for pulmonary arterial hypertension in pediatric patients

A study to assess the efficacy, safety, pharmacokinetics, and related polymorphism of medicines for pulmonary arterial hypertension in pediatric patients - A study to assess the efficacy, safety, pharmacokinetics, and related polymorphism of medicines for pulmonary arterial hypertension in pediatric patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000010355

Enrollment

100

Registered

2013-04-01

Start date

2013-04-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. PAH patients <20 years of age 2. Patients taking PAH medicines (Endothelin receptor antagonist, PDE5 inhibitor, oral prostanoid) 3. Signed informed consent prior to blood sampling for this study.

Exclusion criteria

Exclusion criteria: No exclusion criteria

Design outcomes

Primary

Measure	Time frame
To assess PK/PD based on plasma concentration of PAH medicines, as well as efficacy and safety in PAH pediatric patients.	—

Secondary

Measure	Time frame
To explore gene polymorphisms relating to pharmacokinetics, efficacy, and safety of PAH medicines.	—

Countries

Japan

Contacts

Public ContactKeita Hirai

University of Shizuoka Department of clinical pharmacology and genetics

hiraik@u-shizuoka-ken.ac.jp054-264-5674

Outcome results