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

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ClinicalTrials.gov Identifier: NCT01470144
Recruitment Status : Completed
First Posted : November 11, 2011
Results First Posted : December 9, 2016
Last Update Posted : June 26, 2017
Sponsor:
Collaborators:
Chiltern International Ltd.
Effi-stat
Information provided by (Responsible Party):
Actelion

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Epoprostenol Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : June 1, 2011
Actual Primary Completion Date : June 1, 2015
Actual Study Completion Date : July 1, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Treatment-emergent Adverse Events [ Time Frame: On average 2.72 years ]

Secondary Outcome Measures :
  1. Exposure Duration [ Time Frame: On average 2.72 years ]
    Duration of exposure to EFI


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Chiltern International Ltd.
Effi-stat
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01470144     History of Changes
Other Study ID Numbers: AC-066A302
First Posted: November 11, 2011    Key Record Dates
Results First Posted: December 9, 2016
Last Update Posted: June 26, 2017
Last Verified: June 2017

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