NCT01104870

A Dose Response Study of UT-15C SR in Patients With Exercise-Induced Pulmonary Hypertension

A 12-Week, Randomized, Dose Response Study of UT-15C (Treprostinil Diethanolamine) SR in Patients With Exercise-Induced Pulmonary Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	UT-15C	oral

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2010-04-16
• Last updated: 2016-05-27
• Results posted: 2015-12-30

Locations

9 sites across 1 country: United States