A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

A Phase 3, Multi-Center, Open Label Study to Investigate Safety and efficacy of Sitaxentan THERAPY in japanese Subjects with Pulmonary Arterial Hypertension

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221332

Enrollment

Registered

2010-12-09

Start date

2010-12-09

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

investigational material(s) Generic name etc : Sitaxentan sodium INN of investigational material : Sitaxentan Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Has a current diagnosis of symptomatic PAH 2.Has 6MWT distances from 150 to 450 meters and distance

Exclusion criteria

Exclusion criteria: 1.Previous exposure to an endothelin receptor antagonist 2.Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mm Hg or sitting diastolic blood pressure >100 mm Hg at Screening 3.Has hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5 minutes at Screening

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events Change from baseline in 6-minute walk distance 12 weeks	—

Secondary

Measure	Time frame
Change from baseline in WHO functional class Change from baseline in Haemodynamics parameters Change from baseline in NT-pro BNP Clinical Worsening *Pharmacokinetic parameters 12 weeks	—

Outcome results

None listed

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