Clinical Trial: Epoprostenol for Injection in Pulmonary Arterial Hypertension

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

Official Title: A Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients W

Brief Summary: This is a prospective, multi-center, open-label, randomized, Phase IV exploratory study comparing safety, tolerability, pharmacokinetics, and effectiveness of ACT-385781A and Flolan (epoprostenol sodium) in patients with pulmonary arterial hypertension who are naïve to injectable prostanoid treatment and in need of such treatment. Approximately 30 patients from 8 U.S. clinical sites will be randomized to receive either ACT-385781A or Flolan (2:1 respectively) for 28 days of treatment.

Detailed Summary:
Sponsor: Actelion

Current Primary Outcome:

  • Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 2 ng/kg/Min [ Time Frame: Day 1 ]
    The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.
  • Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 4 ng/kg/Min [ Time Frame: Day 1 ]
    The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.
  • Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 2 ng/kg/Min [ Time Frame: Day 1 ]
    The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.
  • Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 4 ng/kg/Min [ Time Frame: Day 1 ]
    The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.
  • Six-minute Walk Distance (6MWD) - Baseline and Day 28 [ Time Frame: Baseline and 28 days (+3 days) ]
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    Original Primary Outcome: To explore the tolerability and safety of ACT-385781A in comparison to Flolan in patients with PAH in need of injectable prostanoid therapy. [ Time Frame: 1 - 28 days ]

    Current Secondary Outcome:

    Original Secondary Outcome: To explore the pharmacokinetics and the pharmacodynamics of ascending doses of two different formulations of epoprostenol, ACT-385781A and Flolan in patients with PAH. [ Time Frame: 1 - 28 days ]

    Information By: Actelion

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