Ignite Creation Date:
2024-05-06 @ 12:27 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01588405
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2012-01-06
Brief Title:
Remodulin to Oral Treprostinil Transition
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A Multicenter Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin to Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2016-04
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 multi-center open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension PAH from continuous intravenous IV or subcutaneous SC Remodulin infusion to oral treprostinil UT-15C sustained release SR tablets
This study will consist of an in-hospital transition phase dose optimizationevaluation phase and follow up phase
This study will consist of an in-hospital transition phase dose optimizationevaluation phase and follow up phase
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None