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Epoprostenol for Injection (EFI) / ACT-385781A - Pulmonary Arterial Hypertension (EPITOME-2)

This study has been completed.
Information provided by (Responsible Party):
Actelion Identifier:
First received: September 7, 2011
Last updated: March 14, 2013
Last verified: March 2013

September 7, 2011
March 14, 2013
March 2011
February 2012   (final data collection date for primary outcome measure)
Change in cardiac hemodynamics [ Time Frame: Baseline to end of study (3 months) ] [ Designated as safety issue: No ]
Change in cardiac hemodynamics from baseline to end of study (3-months) following switch from Flolan to Epoprostenol
Same as current
Complete list of historical versions of study NCT01431716 on Archive Site
Change in 6-minute walk distance (6MWD) [ Time Frame: Baseline to end of study (3 months) ] [ Designated as safety issue: No ]
Change from basline to end of study (3 months)in 6-minute walk distance (6MWD)
Same as current
Not Provided
Not Provided
Epoprostenol for Injection (EFI) / ACT-385781A - Pulmonary Arterial Hypertension
A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients With Pulmonary Arterial Hypertension

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 Epoprostenol for Injection (EFI)/ ACT-385781A and followed-up for 90 days. During these 90 days safety and tolerability of Epoprostenol for Injection (EFI)/ ACT-385781A will closely be monitored in all treated patients. This 90 follow-up will provide clinical evidence on the safety and tolerability of switching from Flolan® to Epoprostenol for Injection (EFI)/ ACT-385781A in patients with pulmonary arterial hypertension.

Not Provided
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: Epoprostenol for injection
Epoprostenol for injection administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
Other Name: ACT-385781A
Experimental: 1
Epoprostenol for injection
Intervention: Drug: Epoprostenol for injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2012
February 2012   (final data collection date for primary outcome measure)

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 Epoprostenol for injection (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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Italy,   Netherlands,   Spain
Not Provided
Not Provided
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP