An observational study in Pulmonary Arterial Hypertension, sponsored by Janssen Korea, Ltd., Korea. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Janssen Korea, Ltd., Korea (part of Johnson & Johnson) · Observational
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.
773 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's planned enrollment of 333 is above the median of 100 across 201 observational studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Janssen Korea, Ltd., Korea is the lead sponsor of 79 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult participants with pulmonary arterial hypertension who are prescribed Opsynvi according to routine clinical practice in Korea will be observed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Participants with pulmonary arterial hypertension who are prescribed Opsynvi (macitentan/tadalafil fixed-dose combination) based on the locally approved label and the physician's medical judgment will be enrolled. Only data available within routine clinical practice will be collected in this study.
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient administered a medicinal product. An AE does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Time frame: Up to 12 months
Number of Participants With Adverse Drug Reactions (ADRs)
An ADR is defined as a response to a medicinal product that is noxious and unintended. The phrase "response to a medicinal product" means that a causal relationship between a medicinal product and an AE is at least a reasonable possibility.
Time frame: Up to 12 months
Number of Participants With Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that at any dose:(a) Results in death; (b) Is life-threatening; (c) Requires inpatient hospitalization or prolongation of existing hospitalization; (d) Results in persistent or significant disability/incapacity; (e) Is a congenital anomaly/birth defect; (f) Is a suspected transmission of any infectious agent via a medicinal product; (g) Is medically important.
Time frame: Up to 12 months
Number of Participants With Serious Adverse Drug Reactions (SADRs)
Number of participants with SADRs will be reported.
Time frame: Up to 12 months
Number of Participants With Unlisted AE, ADR, SAE, and SADR
Number of participants with unlisted AE, ADR, SAE, and SADR will be reported.
Time frame: Up to 12 months
No study locations are listed for this record.
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Data sharing details ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension →