Pulmonary Hypertension Clinical Trial
Official title:
A 12-Week, Randomized, Dose Response Study of UT-15C (Treprostinil Diethanolamine) SR in Patients With Exercise-Induced Pulmonary Hypertension
This is a prospective, randomized, parallel group study to assess the hemodynamic effect of three different dose regimens of a sustained release (SR) tablet of UT-15C in patients with exercise-induced pulmonary hypertension (PH), as measured by the change in peak total pulmonary resistance index (TPRI) during exercise from Baseline to Week 12.
Prospective, randomized, parallel group study with two periods: a 10 week, dose titration
period, followed by a 2 week, dose maintenance period in patients with exercise-induced PH.
The study population will be randomized into Dose Group 1, Dose Group 2, or an Individual
Maximum Tolerated Dose (iMTD) of UT-15C SR by Week 10 and maintained through Week 12.
Patients may be either currently receiving an approved oral background therapy for their PH
(phosphodiesterase-5 [PDE-5] inhibitor, OR endothelin receptor antagonist [ERA]) (no dual
background therapy), or not currently receiving therapy for PH.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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