Phase 3
N=43
A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study
Hypertension, Pulmonary
Bottom Line
View on ClinicalTrials.gov: NCT04565990 ↗Enrolled (actual)
43
Serious AEs
16.3%
Results posted
Nov 2024
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Selexipag (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Actelion
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
22 | — |
| PRIMARY Number of Participants With TEAEs Leading to Premature Discontinuation of Selexipag |
— | — |
| PRIMARY Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) |
7 | — |
| PRIMARY Number of Participants With Treatment-emergent Deaths |
5 | — |
| PRIMARY Number of Pregnant Females With Maternal Exposure to Selexipag |
— | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04565990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.