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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• 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-066A401

3. Patients who have not obtained authorization for commercial ACT-385781 and Flolan at the time of ending participation in study AC-066A401

Exclusion Criteria:

1. Patients who prematurely discontinued study drug in study AC-066A401

2. Patients for whom continued treatment with either ACT-385781 and Flolan is no longer considered appropriate

3. Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients

4. 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

5. Known concomitant life-threatening disease with a life expectancy < 12 months