Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
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] and/or phosphodiesterase type 5 inhibitor [PDE5-I],
if at a stable dose for ≥30 days). At Baseline, subjects received the first dose of 0.125 mg
UT-15C SR.