Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03187678
Status:
COMPLETED
Last Update Posted:
2019-05-21
First Post:
2017-06-09
Brief Title:
Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Multicenter Open-label Single-sequence Cross-over Study to Assess Safety Tolerability and Pharmacokinetics of Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension Switching From an Oral Stable Dose of Selexipag
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The development of selexipag for intravenous administration will be useful to avoid treatment interruptions in patients with pulmonary arterial hypertension PAH already treated with selexipag administered orally as tablets Uptravi The target population for intravenous selexipag includes those PAH patients who are hospitalized and are unable to swallow tablets of Uptravi
The primary objective of this study is to assess whether it is safe for patients with PAH to temporarily change from selexipag tablets Uptravi to selexipag given directly into a vein intravenous selexipag and then switching back to the initial oral dose of selexipag
The primary objective of this study is to assess whether it is safe for patients with PAH to temporarily change from selexipag tablets Uptravi to selexipag given directly into a vein intravenous selexipag and then switching back to the initial oral dose of selexipag
Detailed Description:
After screening Visit 1 each subject will participate in the following consecutive treatment periods Period 1treatment with oral selexipag at Visit 2Day 1 Period 2 treatment with intravenous selexipag at Visit 2 Day 2 and Day 3 Period 3 treatment with oral selexipag starting in the evening of Visit 2Day 3 and ending 7 to 11 days later at Visit 3 Then a safety follow-up period is planned up to end of study visit EOS which occurs between Day 33 and Day 40
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-004035-21 | EUDRACT_NUMBER | None | None |