The purpose of this study is to determine the safety and efficacy of Iloprost in subjects that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).
This is a randomized, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) with an NYHA Class of III or IV who are receiving conventional therapy and bosentan. Subjects who fulfill the inclusion and exclusion criteria will be randomized to study drug (active or placebo) at a frequency of 6-9 inhalations per day for 12 weeks and will continue conventional therapy and bosentan. At the end of the double-blind phase study, open label Iloprost will be provided.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
University of Alabama at Birmingham
Birmingham, Alabama, United States
UCSD Medical Center
La Jolla, California, United States
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Stanford University Medical Center
Palo Alto, California, United States
UCSF Medical Center
San Francisco, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
The Children's Hospital
Denver, Colorado, United States
University of Colorado HSC
Denver, Colorado, United States
Rush Heart Institute, Center for Pulmonary Heart Disease
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
...and 7 more locations