Macitentan PAH

A multicenter, open-label, phase II/III study to asseses the efficacy, safety and Pharmacokinetics(PK) of macitentan (ACT-064992) in patients with pulmonary arterial hypertension

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221941

Enrollment

Registered

2012-10-17

Start date

2012-10-17

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 : ACT-064992 INN of investigational material : macitentan Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Idiopathic PAH (IPAH); - Heritable PAH (HPAH); - Drug- or toxin-induced PAH; or - PAH associated with: a) Connective tissue disease; or b) Simple, congenital systemic-to-pulmonary shunts at least 1 year post surgical repair

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of macitentan on resting pulmonary vascular resistance (PVR) over a 24-week-period	—

Outcome results

None listed

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