Bosentan PAH (WHO-FC II)

Open label multicenter study to assess the efficacy, safety, and tolerability of bosentan in Japanese patients with pulmonary arterial hypertension (PAH) in WHO functional class II.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221952

Enrollment

Registered

2012-10-26

Start date

2012-10-26

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 INN of investigational material : Bosentan Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * PAH idiopathic * PAH familial * PAH secondary to connective tissue or auto-immune diseases * PAH secondary to atrial septum defect (ASD)<2 cm, ventricular septum defect (VSD) <1 cm or patent ductus arteriosus (PDA)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

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

Outcome results

None listed

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