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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

  • 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 [ Time Frame: 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 [ Time Frame: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication ]


  • Original Primary Outcome: To assess safety and tolerability of ACT-385781A and Flolan in injectable postanoid treatment-naïve patients with PAH [ Time Frame: Day 1 - until patients transition from study medication to commercially-obtained medication ]

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Actelion

    Dates:
    Date Received: April 15, 2010
    Date Started: May 2010
    Date Completion:
    Last Updated: November 29, 2012
    Last Verified: November 2012