Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401

Study Overview
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Brief Summary
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This is an open-label, non-randomized extension to study AC-066A401. The study will assess safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a means for continuing treatment after ending participation in study AC-0066A401.

Official Title
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An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: ACT-385781A (Actelion Epoprostenol)
* Drug: Flolan®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent prior to initiation of any study-mandated procedure Patients who completed participation in study AC-066A401 Patients who have not obtained authorization for commercial ACT-385781 and Flolan at the time of ending participation in study AC-066A401 Exclusion Criteria: Patients who prematurely discontinued study drug in study AC-066A401 Patients for whom continued treatment with either ACT-385781 and Flolan is no longer considered appropriate Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients 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 with a life expectancy < 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ACT-385781A (Actelion Epoprostenol) | Drug: ACT-385781A (Actelion Epoprostenol)<br>* per Prescribing Information<br>|
| Active Comparator: 2<br>Flolan® | Drug: Flolan®<br>* per Prescribing Information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) - Number of Patients With Adverse Events Leading Discontinuation of Study Treatment |  | Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication | 
| Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths |  | Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Arterial Hypertension, PAH, EPITOME-1