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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01470144
Recruitment Status : Completed
First Posted : November 11, 2011
Results First Posted : December 9, 2016
Last Update Posted : June 26, 2017
Chiltern International Ltd.
Information provided by (Responsible Party):

October 28, 2011
November 11, 2011
October 18, 2016
December 9, 2016
June 26, 2017
June 1, 2011
June 1, 2015   (Final data collection date for primary outcome measure)
Treatment-emergent Adverse Events [ Time Frame: On average 2.72 years ]
Treatment-emergent Adverse Events [ Time Frame: up to 24 hours post trial ]
treatment-emergent adverse events up to 24 hours post end of trial
Complete list of historical versions of study NCT01470144 on Archive Site
Exposure Duration [ Time Frame: On average 2.72 years ]
Duration of exposure to EFI
adverse events [ Time Frame: Baseline to end of study (3 months) ]
safety endpoint of adverse events leading to premature discontinuation of study drug
Not Provided
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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
Intervention Model: Single Group Assignment
Masking: None (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: Treatment
Single arm, open-label
Intervention: Drug: Epoprostenol
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 1, 2015
June 1, 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
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Italy,   Netherlands,   Spain
Not Provided
Not Provided
  • Chiltern International Ltd.
  • Effi-stat
Not Provided
June 2017

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