Clareo Health | Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
United Therapeutics
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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
History of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung disease
Use of investigational drug within 30 days of Baseline
