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
  Purpose
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: 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 treatment ]

Secondary Outcome Measures:
  • Exposure Duration [ Time Frame: Study start to end of treatment ]
    Duration of exposure to EFI


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: Treatment
Single arm, open-label
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01470144

Locations
Belgium
UZ Gasthuisberg
Leuven, Belgium, 3000
Canada, Ontario
University of Toronto
Toronoto, Ontario, Canada, M5G 2N2
Canada, Quebec
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
France
CHU Caen
Caen, France
Hôpital Kremlin Bicêtre
Paris, France
Italy
Ospedale Sant'Orsola
Bologna, Italy, 40438
Netherlands
VUMC
Amsterdam, Netherlands
Spain
Hospital 12 de Octubre
Madrid, Spain
Sponsors and Collaborators
Actelion
Effi-stat
Chiltern International Ltd.
  More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01470144     History of Changes
Other Study ID Numbers: AC-066A302 
Study First Received: October 28, 2011
Results First Received: October 18, 2016
Last Updated: October 18, 2016

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on January 23, 2017