Epoprostenol for Injection in Pulmonary Arterial Hypertension

Inclusion Criteria

• •1. Male or female subjects aged 18-65 years
• •2. Patients with the following types of pulmonary arterial hypertension (PAH) belonging to WHO Group I:
• •* Idiopathic (IPAH)
• •* Heritable (HPAH)
• •* Associated (APAH) with
• •* Connective tissue diseases
• •* Drugs and toxins
• •3. Patients with PAH in modified NYHA functional class III or IV at the time of enrollment in need of injectable epoprostenol.
• •4. Patients must be injectable prostanoid treatment-naïve and either
• •* newly diagnosed and not yet treated with specific PAH therapies or
• •* currently treated with existing background PAH therapy with one or more of the following medications for 90 days prior to enrollment and on a stable dose for 30 days prior to enrollment:
• •* Bosentan
• •* Ambrisentan
• •* Sildenafil
• •* Tadalafil
• •5. Women of childbearing potential must use a reliable method of contraception.
• •6. Known hypersensitivity to the formulations of ACT-385781A or any of its excipients, and Flolan or any of its excipients
• •7. Use of inhaled iloprost or treprostinil during the week prior to screening
• •8. Cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of screening
• •9. History of myocardial infarction
• •10. History of left-sided heart disease, including any of the following:
• •* hemodynamically significant aortic or mitral valve disease
• •* restrictive or congestive cardiomyopathy
• •* left ventricular ejection fraction \< 40% by multigated radionucleotide angiogram(MUGA),angiography, or echocardiography
• •* unstable angina pectoris
• •* life-threatening cardiac arrhythmias
• •11. Chronic bleeding disorder
• •12. Infection(s) within the past month that in the mind of the investigator would contraindicate the use of epoprostenol
• •13. Pregnancy or breast-feeding
• •14. Participation in another clinical trial, except observational (noninterventional), or receipt of an investigational product within 30 days prior to randomization
• •15. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
• •16. Known concomitant life-threatening disease other than PAH with a life expectancy \< 12 months