Ignite Creation Date:
2024-05-06 @ 12:03 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01477333
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2011-11-14
Brief Title:
Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
An Evaluation of the Safety and Efficacy of the Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso
Status:
COMPLETED
Status Verified Date:
2017-01
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:
The purpose of this multi-center open-label safety and tolerability study was to assess the addition of oral treprostinil UT-15C sustained release SR tablets to subjects currently receiving Tyvaso treprostinil inhalation solution During the 24-week evaluation period the study evaluated the changes in the following assessments hemodynamics 6-minute walk test 6MWT Borg dyspnea score N-Terminal pro-brain natriuretic peptide NT-proBNP World Health Organization WHO Functional Class and safety assessments
Eligible subjects had a diagnosis of pulmonary arterial hypertension PAH currently were receiving Tyvaso and may have been receiving other approved PAH specific oral therapies endothelin receptor antagonists ERAs andor phosphodiesterase type 5 inhibitor PDE5-I if at a stable dose for 30 days At Baseline subjects received the first dose of 0125 mg UT-15C SR
Eligible subjects had a diagnosis of pulmonary arterial hypertension PAH currently were receiving Tyvaso and may have been receiving other approved PAH specific oral therapies endothelin receptor antagonists ERAs andor phosphodiesterase type 5 inhibitor PDE5-I if at a stable dose for 30 days At Baseline subjects received the first dose of 0125 mg UT-15C SR
Detailed Description:
This was a multi-center open-label safety and tolerability study in WHO Group 1 PAH subjects adding UT-15C SR to Tyvaso and PAH approved background therapy This study had a 24-week evaluation period followed by a long term safety period Six study visits occurred in the first 24 weeks of study Screening Baseline Week 4 Week 8 Week 12 and Week 24 visits Right heart catheterization occurred between 2-4 hours following the last Tyvaso dose at Baseline prior to the administration of UT-15C SR and Week 24
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