Status:
COMPLETED
Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects
Lead Sponsor:
United Therapeutics
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00741819
Start Date
September 1 2008
End Date
December 1 2010
Last Update
February 20 2013
Active Locations (15)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
2
UCSD Medical Center
La Jolla, California, United States, 82037
3
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
4
Kansas University Medical Center
Kansas City, Kansas, United States, 66160