Ignite Creation Date:
2024-05-06 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03626688
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2018-07-27
Brief Title:
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH
Status:
RECRUITING
Status Verified Date:
2024-10
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-301 ADVANCE OUTCOMES is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension PAH standard of care or PAH-specific background therapy in subjects with World Health Organization WHO Group 1 PAH
Detailed Description:
Study ROR-PH-301 is a multicenter randomized double-blind placebo-controlled study Subjects who meet entry criteria will be randomly allocated 11 to receive ralinepag or placebo in addition to their standard of care or PAH-specific background therapy as applicable The primary endpoint is the time in days from randomization to the first adjudicated protocol-defined clinical worsening event All primary endpoint events will be adjudicated by an independent Clinical Event Committee CEC in a blinded fashion Subjects who have a confirmed primary endpoint event adjudicated by the CEC at any time during the study and all subjects on treatment at the conclusion of the study who have completed the Week 28 Visit after the target number of confirmed events is achieved will have the option to enroll in an open-label extension OLE study Subjects who do not choose to participate in the OLE study will discontinue study drug and should remain in the study for long-term follow-up of survival status and will receive standard of care PAH treatment at the discretion of the treating physician
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 |
|---|---|---|---|
| APD811-301 | OTHER | Arena Pharmaceuticals | None |