Overview

Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension

Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
0
Participant gender:
All
Summary
This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Actelion
Collaborators:
Chiltern International Ltd.
Effi-Stat
Treatments:
Epoprostenol
Tezosentan
Criteria
Inclusion Criteria:

1. Signed informed consent prior to initiation of any study-mandated procedure

2. Patients who completed participation in study AC-066A301

3. Patients who have not obtained access for commercial EFI at the time of ending
participation in study AC-066A301

Exclusion Criteria:

1. Patients who prematurely discontinued study drug in study AC-066A301

2. Patients for whom continued treatment with EFI is no longer considered appropriate