Remodulin® to Oral Treprostinil Transition

Status:	Completed
Conditions:	High Blood Pressure (Hypertension)
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	15 - 80
Updated:	5/3/2014
Start Date:	April 2012
End Date:	December 2013
Contact:	Meredith Howell, PharmD
Email:	mhowell@unither.com
Phone:	919-425-5308

A Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

This multi-center, open-label study will assess the tolerability and safety of transitioning
subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV)
or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR)
tablets).

This study will consist of an in-hospital transition phase, dose optimization/evaluation
phase, and follow up phase.

Inclusion Criteria:

- Between 15 and 80 years of age, inclusive, weigh at least 40 kg and have a diagnosis
of PAH

- Have stable disease as confirmed by recent right heart catheterization and a Baseline
6MWD of at least 250 meters

- Have been receiving Remodulin for at least 90 days and at a stable dose for at least
30 days prior to the Baseline visit; the dose of Remodulin must be between 25-75
ng/kg/min, inclusive

- Must be also receiving an endothelin receptor antagonist (ERA) and/or a
phosphodiesterase-5 inhibitor (PDE-5i) for at least 90 days and have been at a stable
dose for at least 30 days prior to Baseline

Exclusion Criteria:

- WHO functional class III and IV subjects will be excluded

We found this trial at

sites

University of Arizona Clinical and Translational Science (CATS) Research Center

Tucson, Arizona 85724

from

Tucson, AZ