Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03187678 | Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension | PHASE3 | COMPLETED | 20 | — | — | Dec 4, 2017 | May 29, 2018 | Jun 29, 2025 | 8 | United States, Germany |
AE is any untoward medical event that occurs in a participant during the course of the study whether or not considered by the investigator as related to the study treatment.
Prostacyclin-associated AE include headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia.
This is the number of participants with at least one clinically significant reaction at the injection site (e.g., erythema/redness, tenderness, swelling, induration, hemorrhage at the injection site) occurring on the days of intravenous (iv) selexipag injection.
This is the number of subjects who discontinued the i.v. selexipag treatment due to prostacyclin-associated adverse events (headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia).
This is the number of participants with at least one AE considered to be related to pulmonary arterial hypertension during the course of the study.
| Arm | Type | Description |
|---|---|---|
| Selexipag | EXPERIMENTAL | Subjects with stable pulmonary arterial hypertension (PAH) and currently treated with a stable oral dose of Uptravi will be switched to i.v. selexipag from Day 2 to Day 3 (2 infusions on Day 2 and 1 infusion on Day 3). Otherwise, they will continue with their current oral selexipag treatment throughout the study. |
| Name | Type | Description |
|---|---|---|
| i.v. selexipag | DRUG | Selexipag for intravenous administration, twice daily as an infusion over 87 min. The dose is individualized for each subject to correspond to his/her current oral dose of Uptravi®. |
| oral selexipag (Uptravi) | DRUG | Uptravi is used as an auxiliary medicinal product, as part of the PAH standard treatment and administered according to the local prescribing information |
Inclusion Criteria: * Signed informed consent form prior to any study-mandated procedure. * Male and female subjects aged from 18 to 75 years (inclusive), * Subjects with stable pulmonary arterial hypertension (PAH) defined as WHO Functional Class I-III at Visit 1 and Visit 2, and no change (i.e., ...