A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Suspected or known pulmonary veno-occlusive disease.

- Known allergies, hypersensitivity, or intolerance to selexipag or its excipients.

- 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.

- Uncontrolled thyroid disease.

- Known and documented severe hepatic impairment, example, Child-Pugh Class C.

- 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.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04565990
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Actelion
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Actelion Clinical Trial
Principal Investigator Affiliation	Actelion
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Belarus, India, Korea, Republic of, Romania, Taiwan, Ukraine
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hypertension, Pulmonary

Arms & Interventions

Arms

Experimental: Selexipag

Participants will receive selexipag tablets twice daily with the dose strength corresponding to their individual maximum tolerated dose (iMTD) from the parent study.

Interventions

Drug: - Selexipag

Selexipag tablets will be administered orally at all dose strengths (200, 400, 600, 800, 1000, 1200, 1400 and 1600 microgram) twice daily.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Minsk, Belarus

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Address

The Republican Scientific-Practical Center ''Cardiology''

Minsk, , 220036

Minsk Regional Clinical Hospital, Minsk, Belarus

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Minsk Regional Clinical Hospital

Minsk, , 220143

Sanjivani Hospitals, Ahmedabad, India

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Sanjivani Hospitals

Ahmedabad, , 380015

Apollo Hospitals, Chennai, India

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Apollo Hospitals

Chennai, , 600006

Gachon University Gil Medical Center, Incheon, Korea, Republic of

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Gachon University Gil Medical Center

Incheon, , 21565

Samsung Medical Center, Seoul, Korea, Republic of

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Samsung Medical Center

Seoul, , 06351

Seoul, Korea, Republic of

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The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, , 06591

Bucuresti, Romania

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Institutul de pneumoftiziologie Marius Nasta

Bucuresti, , 050152

Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

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Kaohsiung Veterans General Hospital

Kaohsiung, , 813

National Taiwan University Hospital, Taipei, Taiwan

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National Taiwan University Hospital

Taipei, , 10002

Dnipro, Ukraine

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Municipal Inst. Of Dnipropetrovsk Region. Council

Dnipro, ,

Kharkiv, Ukraine

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Health Care Municipal Institution City Clinical Hospital #13

Kharkiv, ,

Kyiv, Ukraine

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State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

Kyiv, , 03680

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