Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension (Epitome2ext)
This study has been completed.
Sponsor:
Actelion
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01470144
First received: October 28, 2011
Last updated: December 14, 2015
Last verified: December 2015
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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: | 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:
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: 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.
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| 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 - 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
Actelion
More Information
| Responsible Party: | Actelion |
| ClinicalTrials.gov 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:
|
Hypertension Familial Primary Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases |
Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on September 27, 2016