FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
United Therapeutics
Age
12–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Between 12 and 70 years of age, inclusive.
Body weight at least 45 kg (approximately 100 pounds).
PAH that is either idiopathic/heritable (including PAH associated with appetite suppressant/toxin use); PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); PAH associated with collagen vascular disease; or PAH associated with HIV.
Baseline 6-minute walk distance between 150 and 450 meters, inclusive.
Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days.
Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
Reliable and cooperative with protocol requirements.
History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.
Use of an investigational drug within 30 days of Baseline.
You may not be if
Nursing or pregnant.
Received a prostacyclin within the past 30 days.
Clareo Health | FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)