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

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona 85013

from

Phoenix, AZ