Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Actelion
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study
