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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
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.

Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Epoprostenol
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)

Resource links provided by NLM:

Further study details as provided by Actelion:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Enrollment: 41
Study Start Date: June 2011
Study Completion Date: July 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: epopropstenol 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.


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01470144

UZ Gasthuisberg - Site 201
Leuven, Belgium, 3000
Canada, Ontario
Univesrity of Toronto
Toronoto, Ontario, Canada, M5G 2N2
Canada, Quebec
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
  More Information

Responsible Party: Actelion Identifier: NCT01470144     History of Changes
Other Study ID Numbers: AC-066A302 
Study First Received: October 28, 2011
Last Updated: December 14, 2015
Health Authority: Spain: Comité Ético de Investigación Clínica
Canada: Ethics Review Committee
Italy: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Committee for the Protection of Personnes
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Canada: Health Canada

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases processed this record on December 02, 2016