Ignite Creation Date:
2024-05-06 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03683186
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2018-09-19
Brief Title:
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A Phase 3 Open-label Extension OLE Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization WHO Group 1 Pulmonary Arterial Hypertension PAH
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
Study ROR-PH-303 ADVANCE EXTENSION is an open-label extension OLE study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag
Detailed Description:
Study ROR-PH-303 is a multicenter open-label extension OLE study for subjects with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag and who qualify for entry based upon participation in the prior study Subjects who discontinue participation in a prior study due to safety issues related to study medication or who fail to complete study procedures will not be eligible to enter Study ROR-PH-303 Subjects who meet all OLE entry criteria will be enrolled and will receive ralinepag in addition to their pre-existing PAH disease-specific background therapy
For subjects who are enrolled from an ongoing double-blind Phase 2 or Phase 3 ralinepag study a 16-week blinded Dose Titration Period will be completed following enrollment into the OLE Subjects previously on ralinepag will continue on the same dose during the Dose Titration Period as received in the original study and will also initiate placebo treatment in the OLE
Subjects who are enrolled from a non-blinded study or another OLE will not participate in the blinded Dose Titration Period in Study ROR-PH-303 but will be enrolled directly into the Treatment Period and continue on the dose of ralinepag received in the original study
All subjects will receive ralinepag in the OLE study until premature discontinuation of ralinepag due to an AEserious adverse event SAE or other reason marketing approval of ralinepag is granted in the region in which the study is conducted or the study is discontinued by the Sponsor
For subjects who are enrolled from an ongoing double-blind Phase 2 or Phase 3 ralinepag study a 16-week blinded Dose Titration Period will be completed following enrollment into the OLE Subjects previously on ralinepag will continue on the same dose during the Dose Titration Period as received in the original study and will also initiate placebo treatment in the OLE
Subjects who are enrolled from a non-blinded study or another OLE will not participate in the blinded Dose Titration Period in Study ROR-PH-303 but will be enrolled directly into the Treatment Period and continue on the dose of ralinepag received in the original study
All subjects will receive ralinepag in the OLE study until premature discontinuation of ralinepag due to an AEserious adverse event SAE or other reason marketing approval of ralinepag is granted in the region in which the study is conducted or the study is discontinued by the Sponsor
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 |
|---|---|---|---|
| APD811-303 | OTHER | Arena Pharmaceuticals | None |