Ignite Creation Date:
2024-05-06 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03497689
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2018-03-20
Brief Title:
EXPEDITE A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
EXPEDITE A 16-Week Multicenter Open-label Study of Remodulin Induction Followed by Orenitram Optimization in Subjects With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2023-08
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:
This was a multicenter open-label study to evaluate the dose of Orenitram treprostinil Extended Release Tablets achieved at 16 weeks after a short-term course of Remodulin treprostinil Injection in subjects with pulmonary arterial hypertension PAH
Detailed Description:
Subjects were initiated on subcutaneous SC or intravenous IV treprostinil and titrated to a dose that improved the symptoms of PAH while minimizing excessive pharmacologic effects After achieving a minimum SCIV treprostinil dose of 20 ngkgmin subjects began a transition to oral treprostinil at the Transition Visit which occurred at the Week 2 4 or 8 study visit After the Transition Visit oral treprostinil titration continued through Week 16 to reach the maximum tolerated dose MTD
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