Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects

Completed · Phase 4

Conditions studied: Pulmonary Arterial Hypertension

In brief

This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects following transition from a stable dose of inhaled iloprost (Ventavis). Subjects are to be evaluated for safety throughout the course of the study while secondary assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24 following initiation of treprostinil sodium.

Key facts

Study ID

NCT00741819

Run by

United Therapeutics

People needed

73

Starts

2008-09-01

Expected to finish

2010-12-01

Last updated by the study team

2013-02-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 18 and 75 years of age
• PAH diagnosis defined by following WHO Group I categories: idiopathic/familial, associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired >/= 5 years), associated with collagen vascular disease, associated with HIV, associated with appetite suppressant/toxin use
• Baseline six-minute walk distance (6MWD) >/= 250 meters
• Currently receiving Ventavis and be stable at current dose for 30 days prior to Baseline
• If currently receiving other approved background therapy (i.e. endothelin receptor antagonist or phosphodiesterase-5-inhibitor or both) must be on stable dose for 30 days prior to Baseline
• Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH

You may not qualify if…

• Nursing or pregnant
• Has acute concomitant disease (e.g. portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, etc) other than those accepted as part of the inclusion criteria or has had atrial septostomy
• History of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung disease
• Use of investigational drug within 30 days of Baseline

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• UCSD Medical Center — La Jolla, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Long Island Jewish Medical Center - North Shore — New Hyde Park, New York, United States
• Beth Israel Medical Center — New York, New York, United States
• Cornell University Medical Center — New York, New York, United States
• Columbia Presbyterian Medical Center — New York, New York, United States
• Mary M. Parkes Center for Asthma, Allergy and Pulmonary Care — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburg Medical Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.