NCT04565990CompletedPhase 3
A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study
A Multicenter, Single-arm, Open-label, Long-term Follow-up Safety Study of Selexipag in Participants Who Participated in a Previous Selexipag Study
Source: ClinicalTrials.gov · Last updated 1 May 2025
Brief summary (registry, in English)
The purpose of this study is to assess the long-term safety of selexipag while providing continued selexipag treatment for participants who were previously enrolled in an Actelion-sponsored study with selexipag and who derived benefit from selexipag in indications for which a positive benefit-risk has been established.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 22 Sept 2020
- Start date
- 3 May 2021
- Primary completion date
- 10 Nov 2023
- Lead sponsor
- Actelion
- Diseases
- High blood pressure
- NCT number
- NCT04565990
- EudraCT number
- 2020-000475-21
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 43
- From 3 May 2021 to the primary completion date, 10 Nov 2023
- 13 sites in 6 countries
- 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.
Prior treatment
- Taken any disallowed therapies, Concomitant Therapy before the planned first dose of study intervention: a) treatment with a strong CYP 2C8 inhibitor (example, gemfibrozil); b) treatment with oral prostacyclin analogs (example, beraprost, treprostinil) since the last dose of study intervention taken in the parent study; c) any investigational treatment other than selexipag
Other illness
- Suspected or known pulmonary veno-occlusive disease
- Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
- Uncontrolled thyroid disease
- Known and documented severe hepatic impairment, example, Child-Pugh Class C
- Severe coronary heart disease or unstable angina, myocardial infarction within the last 6 months, decompensated cardiac failure if not under close medical supervision, severe arrhythmia, cerebrovascular events (example, transient ischemic attack, stroke) within the last 3 months, or congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to PH
Other
- Interruption of study intervention for more than 14 days since the last dose of study intervention taken in the parent study
- Female participant being pregnant, or breastfeeding, or planning to become pregnant at the time of screening and while enrolled in this study
Who the study is looking for
- Treated with selexipag at the end of a parent study and: a) the parent study has established efficacy with a favorable benefit/risk profile for the indication under investigation; b) participant may continue to benefit from treatment with selexipag; c) has completed the end of treatment (EOT) visit of the parent study; d) no alternative means of access to selexipag have been identified
- Women of childbearing potential must use an acceptable method of contraception throughout the study and until at least 1 month following the last dose of study intervention
- Women of childbearing potential must have a negative urine (or serum if applicable) pregnancy test at screening on Day 1 or at the last visit of the parent study
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Republican Scientific-Practical Center ''Cardiology'' Coordinator of this site? Confirm its status | Minsk | Belarus | Unknown status |
| Minsk Regional Clinical Hospital Coordinator of this site? Confirm its status | Minsk | Belarus | Unknown status |
| Sanjivani Hospitals Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Apollo Hospitals Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| The Catholic University of Korea Seoul St Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Institutul de pneumoftiziologie Marius Nasta Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Kaohsiung Veterans General Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Municipal Inst. Of Dnipropetrovsk Region. Council Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Health Care Municipal Institution City Clinical Hospital #13 Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.