Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401 (EPITOME-1 Ext)

Actelion Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Pulmonary Arterial Hypertension

Treatments

Drug: Flolan®

Drug: ACT-385781A (Actelion Epoprostenol)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01105117

AC-066A402

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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