Health Condition 1: I270- Primary pulmonary hypertension
Conditions
Interventions
Intervention1: Selexipag: Selexipag tablets will be administered orally at all dose strengths (200, 400, 600, 800, 1000, 1200, 1400 and 1600 microgram) twice daily for 5 years.
Control Intervention1:
Sponsors
Johnson Johnson Private Limited
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Frequency of Adverse Events (AEs) -Frequency of AEs Leading to Premature Discontinuation of Selexipag -Frequency of Serious Adverse Events (SAEs) -Frequency of Death -Number of Pregnancies with Maternal Exposure to Selexipag Timepoint: From Day 1 up to 7 years (end of study) | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
Belarus, India, Republic of Korea, Romania, Taiwan, Ukraine
Contacts
Public ContactDr Sanish Davis
Johnson & Johnson Private Limited
Outcome results
None listed