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Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension (Epitome2ext)

This study has been completed.
Information provided by (Responsible Party):
Actelion Identifier:
First received: October 28, 2011
Last updated: December 14, 2015
Last verified: December 2015

October 28, 2011
December 14, 2015
June 2011
June 2015   (final data collection date for primary outcome measure)
treatment-emergent adverse events [ Time Frame: up to 24 hours post trial ] [ Designated as safety issue: Yes ]
treatment-emergent adverse events up to 24 hours post end of trial
Same as current
Complete list of historical versions of study NCT01470144 on Archive Site
adverse events [ Time Frame: Baseline to end of study (3 months) ] [ Designated as safety issue: Yes ]
safety endpoint of adverse events leading to premature discontinuation of study drug
Same as current
Not Provided
Not Provided
Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension
An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)
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.
Not Provided
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: Epoprostenol
Administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit.
Experimental: epopropstenol
Intervention: Drug: Epoprostenol
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2015
June 2015   (final data collection date for primary outcome measure)

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
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada
Not Provided
Not Provided
Not Provided
Not Provided
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP