NCT07890285Not yet recruiting
A Study of Opsynvi in Adults Participants With Pulmonary Arterial Hypertension in Korea
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 333 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- 2 Nov 2026
- Primary completion date
- 29 Oct 2032
- Lead sponsor
- Janssen Korea, Ltd., Korea
- NCT number
- NCT07890285
What you commit to
- Study type: Observational
- Planned participants: 333
- From 2 Nov 2026 to the primary completion date, 29 Oct 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.