Pulmonary Arterial HypertensionOpsynvi RMPNCT07890285
A Study of Opsynvi in Adults Participants With Pulmonary Arterial Hypertension in Korea
An observational study of Pulmonary Arterial Hypertension, run by Janssen Korea, Ltd., Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- How many people
- 333 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 29 Oct 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with pulmonary arterial hypertension who are prescribed Opsynvi according to routine clinical practice in Korea will be observed.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Pulmonary Arterial Hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Pulmonary Arterial Hypertension | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Number of Participants With Serious Adverse Drug Reactions (SADRs)
Number of participants with SADRs will be reported.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion29 Oct 2032 (estimated)
- Study completion29 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890285
- Sponsor's protocol ID
- 68150420PAH4001
- Acronym
- Opsynvi RMP
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.