Conditions: Pulmonary Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: UT-15C 0.25 mg twice daily arm 2: UT-15C 1.25 mg twice daily arm 3: UT-15C individual Maximum Tolerated Dose

Interventions: intervention 1: UT-15C
Intervention descriptions: intervention 1: oral

Protocol document: