Observes safety of Opsynvi in adults with pulmonary arterial hypertension in Korea
Studies how safe Opsynvi is in adults with pulmonary arterial hypertension.
Plain-language title generated from the registry record
Registry title: A Study of Opsynvi in Adults Participants With Pulmonary Arterial Hypertension in Korea
Key facts
- Where
- Busan, South KoreaSee the site
Where in South Korea
- Pusan National University HospitalBusan, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Korea, Ltd., Korea
- Trial code
- NCT07890285
- Record updated
- 3 November 2026
- Original description
The purpose of this study is to evaluate how safe Opsynvi (macitentan/tadalafil fixed-dose combination) is in adult participants with pulmonary arterial hypertension under routine clinical practice in Korea. Pulmonary arterial hypertension is a condition where the blood vessels that carry blood from the heart to the lungs become narrowed or stiff.Read full original descriptionShow less
A Prospective Observational Study to Evaluate Safety and Effectiveness of Opsynvi (Macitentan/Tadalafil Fixed Dose Combination) in Adult Patients With Pulmonary Arterial Hypertension in Korea
The purpose of this study is to evaluate how safe Opsynvi (macitentan/tadalafil fixed-dose combination) is in adult participants with pulmonary arterial hypertension under routine clinical practice in Korea. Pulmonary arterial hypertension is a condition where the blood vessels that carry blood from the heart to the lungs become narrowed or stiff.
Inclusion: Participants who must be prescribed macitentan/tadalafil fixed dose combination (M/T FDC) based on the locally approved label and the physician's medical judgment; Participants who must sign a participation agreement/ICF allowing source data verification in accordance with local requirements.
Exclusion: Participants who have any contraindications to M/T FDC, based on the locally approved label; Participants who currently are participating in other interventional clinical trials.