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Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension (Epitome2ext)
This study has been completed.
Sponsor:
Actelion
Collaborators:
Chiltern International Ltd.
Effi-stat
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01470144
First received: October 28, 2011
Last updated: June 1, 2017
Last verified: June 2017
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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: 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
pulmonary arterial hypertension
Drug Information available for:
Epoprostenol
U.S. FDA Resources
Further study details as provided by Actelion:
Primary Outcome Measures:
- Treatment-emergent Adverse Events [ Time Frame: On average 2.72 years ]
Secondary Outcome Measures:
- Exposure Duration [ Time Frame: On average 2.72 years ]Duration of exposure to EFI
| Enrollment: | 41 |
| Actual Study Start Date: | June 1, 2011 |
| Study Completion Date: | July 1, 2015 |
| Primary Completion Date: | June 1, 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:
- 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
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
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
Chiltern International Ltd.
Effi-stat
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: | June 1, 2017 |
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 August 22, 2017