Ignite Creation Date:
2024-05-06 @ 12:23 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01560637
Status:
COMPLETED
Last Update Posted:
2022-06-02
First Post:
2012-03-09
Brief Title:
An Open-Label Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310
Status:
COMPLETED
Status Verified Date:
2022-05
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:
This study is an international multi-center open-label study designed to provide oral treprostinil UT-15C to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity
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