Drug interactions and effects of combination therapy for pulmonary arterial hypertension

Drug interactions and effects of combination therapy for pulmonary arterial hypertension - Drug interactions and effects of PAH combination therapy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005464

Enrollment

Registered

2011-04-19

Start date

2011-04-01

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

phase 1: sildenafil (60mg/day) and bosentan (250mg/day) for 4 or 5 weeks phase 2: sildenafil(60mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks phase 3: tadalafil (40mg/day) and ambrisentan (5mg/da

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Males or females over 20 years of age with pulmonary arterial hypertension in WHO functional classes I or II. No history of drug allergy. No history of drug and alchohol abuse. Written informed concent obtained.

Exclusion criteria

Exclusion criteria: Unstable disease conditions. Disabilities of walk. Home oxygen therapy. Ineligible patients judged by principal. investigator.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics in the last week of each phase: sildenafil, bosentan, ambrisentan and tadalafil. Exercise tolerability test: 6 minute walk test, shattle walking test and maximal oxygen consumption test.	—

Countries

Japan

Contacts

Public ContactKazuhiko Takeuchi

Hamamatsu University School of Medicine Clinical Pharmacology and Therapeutics

takeutik@hama-med.ac.jp053-435-2385

Outcome results

None listed

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