Status:
COMPLETED
Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension
Lead Sponsor:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 pu...
Eligibility Criteria
Inclusion
- Male or female aged 18 years and above
- 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
- Patients treated with Flolan® for at least 12 months and on a stable dose for at least 3 months prior to enrollment
- 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
- Women of childbearing potential must use a reliable method of contraception
- Signed informed consent prior to initiation of any study mandated procedure
Exclusion
- Patients with respiratory and/or cardiovascular distress in need of emergency care
- Known or suspicion of pulmonary veno-occlusive disease (PVOD)
- Current use of IV inotropic agents
- Current use of any prostacyclin or prostacyclin analog other than Flolan®
- Tachycardia with heart rate \> 120 beats/min at rest
- PAH related to any condition other than those specified in the inclusion criteria
- Known hypersensitivity to the formulations EFI/ACT-385781A or any of its excipients, and Flolan® or any of its excipients
- Cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of screening
- History of myocardial infarction
- 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
- Chronic bleeding disorders
- Central venous line infection within 90 days prior to screening and/or a history of recurring line infections
- Women who are pregnant or breast-feeding
- Participation in another clinical trial, except observational, or receipt of an investigational product within 30 days prior to randomization
- 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
- Known concomitant life-threatening disease other than PAH with a life expectancy \< 12 months
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01431716
Start Date
March 1 2011
End Date
July 1 2012
Last Update
January 13 2015
Active Locations (8)
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1
UZ Gasthuisberg
Leuven, Belgium, 3000
2
University Health Network, Toronto TGH - 10 EN - 220
Toronto, Ontario, Canada, M5G 2N2
3
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1 E2
4
Centre Hospitalier Universitaire
Caen, France, 14033