Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Collaborators:
Effi-stat
Chiltern International Ltd.
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01470144
First received: October 28, 2011
Last updated: October 18, 2016
Last verified: October 2016

October 28, 2011
October 18, 2016
June 2011
June 2015   (Final data collection date for primary outcome measure)
Treatment-emergent Adverse Events [ Time Frame: Up to 24 hours post treatment ]
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 ClinicalTrials.gov Archive Site
Exposure Duration [ Time Frame: Study start to end of treatment ]
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
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
Interventional
Phase 3
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: Treatment
Single arm, open-label
Intervention: Drug: Epoprostenol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Italy,   Netherlands,   Spain
 
 
NCT01470144
AC-066A302
No
Not Provided
Not Provided
Not Provided
Actelion
Actelion
  • Effi-stat
  • Chiltern International Ltd.
Not Provided
Actelion
October 2016

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