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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01470144
First received: October 28, 2011
Last updated: March 14, 2013
Last verified: March 2013

October 28, 2011
March 14, 2013
June 2011
March 2014   (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 ClinicalTrials.gov 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
Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
41
April 2014
March 2014   (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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada
 
NCT01470144
AC-066A302
No
Actelion
Actelion
Not Provided
Not Provided
Actelion
March 2013

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