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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Arterial Hypertension | Drug: Epoprostenol | Phase 3 |
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 |

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
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- Treatment-emergent Adverse Events [ Time Frame: On average 2.72 years ]
- Exposure Duration [ Time Frame: On average 2.72 years ]Duration of exposure to EFI

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed informed consent prior to initiation of any study-mandated procedure
- Patients who completed participation in study AC-066A301
- Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301
Exclusion Criteria:
- Patients who prematurely discontinued study drug in study AC-066A301
- Patients for whom continued treatment with EFI is no longer considered appropriate

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
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 |
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 |