Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: EFI/ACT-385781A
Intervention MeSH terms: Epoprostenol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is investigating the effect of switching from Flolan® to Epoprostenol for
      Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated
      with Flolan®. For this purpose patients being treated for at least 12 months with Flolan®
      will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these 90
      days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated
      patients. This 90 follow-up will provide clinical evidence on the safety, tolerability,
      efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients
      with pulmonary arterial hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged 18 years and above

          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 or Drugs and toxins

          3. Patients treated with Flolan® for at least 12 months and on a stable dose for at least
             3 months prior to enrollment

          4. Patients who are currently treated with concomitant PAH therapy listed below must have
             been treated for at least 90 days and on a stable dose for 30 days prior to
             enrollment: Bosentan, Ambrisentan, Sitaxsentan, Sildenafil, Tadalafil

          5. Women of childbearing potential must use a reliable method of contraception

          6. Signed informed consent prior to initiation of any study mandated procedure

        Exclusion Criteria:

          1. Patients with respiratory and/or cardiovascular distress in need of emergency care

          2. Known or suspicion of pulmonary veno-occlusive disease (PVOD)

          3. Current use of IV inotropic agents

          4. Current use of any prostacyclin or prostacyclin analog other than Flolan®

          5. Tachycardia with heart rate > 120 beats/min at rest

          6. PAH related to any condition other than those specified in the inclusion criteria

          7. Known hypersensitivity to the formulations EFI/ACT-385781A or any of its excipients,
             and Flolan® or any of its excipients

          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 disorders

         12. Central venous line infection within 90 days prior to screening and/or a history of
             recurring line infections

         13. Women who are pregnant or breast-feeding

         14. Participation in another clinical trial, except observational, 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