Epoprostenol for Injection in Pulmonary Arterial Hypertension

Status:	Archived
Conditions:	High Blood Pressure (Hypertension)
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	March 2010
End Date:	June 2011

A Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to FlolanÂ® in Injectable Prostanoid Treatment-naÃ¯ve Patients With Pulmonary Arterial Hypertension (PAH)

This is a prospective, multi-center, open-label, randomized, Phase IV exploratory study
comparing safety, tolerability, pharmacokinetics, and effectiveness of ACT-385781A and
Flolan (epoprostenol sodium) in patients with pulmonary arterial hypertension who are naÃ¯ve
to injectable prostanoid treatment and in need of such treatment. Approximately 30 patients
from 8 U.S. clinical sites will be randomized to receive either ACT-385781A or Flolan (2:1
respectively) for 28 days of treatment.

We found this trial at

sites

UT Soutwestern Medical Center at Dallas

5303 Harry Hines Boulevard
Dallas, Texas 75390

(214) 648-3111