Pulmonary Arterial Hypertension MedDRA version: 12.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension
Conditions
Interventions
Trade Name: Epoprostenol-Actelion
Product Name: Epoprostenol-Actelion
Product Code: ACT-385781A
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: EPOPROSTENOL SODIUM
CAS Numb
Sponsors
ACTELION Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion 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 o Connective tissue diseases o Drugs and toxins 3. Patients treated with Flolan® for at least 12 months and on a stable dose for at least 3 month 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 Epoprostenol-Actelion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the change in cardiac hemodynamics from baseline to 3-month following switch from Flolan® to Epoprostenol-Actelion in patients with pulmonary arterial hypertension (PAH). • To evaluate the safety and tolerability of switching from Flolan® to Epoprostenol-Actelion in patients with PAH. ;Secondary Objective: ;Primary end point(s): Tolerability / Safety endpoints: • Treatment-emergent adverse events (AEs) up to 24 hours post-EOT • Change from baseline to EOT in vital signs [heart rate (HR) and blood pressure (BP)] and body weight • AEs leading to premature discontinuation of study drug • Treatment-emergent serious AEs (SAEs) up to 30 days post-EOT Efficacy endpoint: • Change from baseline to EOT in cardiac hemodynamics including: o Pulmonary vascular resistance (PVR) o Mean pulmonary arterial pressure (mPAP) o Right atrial pressure (RAP) o Pulmonary artery occlusion pressure (PAOP) o Cardiac index (CI) | — |
Countries
Belgium, France, Italy, Netherlands, Spain
Outcome results
None listed