WHO ICTRP trial
A Study of Macitentan in Japanese Pediatric Patients with Pulmonary Arterial…
EUCTR2023-000984-30-Outside-EU/EEA · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2023-000984-30-Outside-EU/EEA |
|---|---|
| Public title | A Study of Macitentan in Japanese Pediatric Patients with Pulmonary Arterial Hypertension |
| Scientific title | A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of Macitentan in Japanese Pediatric Patients (=3 months to <15 years) with Pulmonary Arterial Hypertension |
| Primary sponsor | Janssen Pharmaceutical K.K. |
| Registry | EU Clinical Trials Register |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Japan |
| Conditions | Pulmonary arterial hypertension MedDRA version: 21.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C]… |
| Interventions | Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 Pharmaceutical Form: Dispersible tablet |
| Registration date | Mar 1, 2024 |
| Secondary IDs | 67896062PAH3001 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: