clinical trial · NCT01105091
Epoprostenol for Injection in Pulmonary Arterial Hypertension
Actelion·phase4·completed·n = 30
Pulmonary Arterial HypertensionACT-385781A (Actelion Epoprostenol)Flolan®
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.
started
Mar 1, 2010
primary completion
May 1, 2011
completion
Jul 1, 2011
last updated
Feb 4, 2025
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 With Pulmonary Arterial Hypertension (PAH)
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