Bosentan for PAH pediatric patients

Open-label, multicenter study to assess the efficacy, safety, tolerability, and pharmacokinetics of bosentan in Japanese children with pulmonary arterial hypertension

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222108

Enrollment

Registered

2013-06-11

Start date

2013-06-11

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 (PAH)

Interventions

investigational material(s) Generic name etc : Ro47-0203 / ACT-050088 INN of investigational material : bosentan Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Idiopathic PAH, Heritable PAH, PAH associated with CHD

Exclusion criteria

Exclusion criteria: Co-exisiting hepatic impairment etc.

Design outcomes

Primary

Measure	Time frame
Changes in cardiopulmonary hemodynamics (PVR ) from baseline to week 12 of treatment RHC	—

Secondary

Measure	Time frame
To evaluate the effect of bosentan on other hemodynamic variables and WHO functional class, the pharmacokinetics (PK) of bosentan, safety and tolerability. RHC, Blood samples	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026