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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Actelion

ClinicalTrials.gov Identifier:

NCT01431716

First received: September 7, 2011

Last updated: March 14, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 7, 2011
Last Updated Date	March 14, 2013
Start Date ^ICMJE	March 2011
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 9, 2011)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01431716 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 9, 2011)	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)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Epoprostenol for Injection (EFI) / ACT-385781A - Pulmonary Arterial Hypertension
Official Title ^ICMJE	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
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 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Pulmonary Arterial Hypertension
Intervention ^ICMJE	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
Study Arm (s)	Experimental: 1 Epoprostenol for injection Intervention: Drug: Epoprostenol for injection
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	42
Completion Date	July 2012
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Criteria: 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 Epoprostenol for injection (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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium, Canada, France, Italy, Netherlands, Spain

Administrative Information
NCT Number ^ICMJE	NCT01431716
Other Study ID Numbers ^ICMJE	AC-066A301
Has Data Monitoring Committee	No
Responsible Party	Actelion
Study Sponsor ^ICMJE	Actelion
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Actelion
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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