20 completed, 2 terminated, 1 unknown. 12 Phase 4, 3 Phase 2, 2 Not applicable, 2 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 12 | Completed 11, Terminated 1 |
| Phase 2 | 3 | Completed 2, Terminated 1 |
| Not applicable | 2 | Completed 1, Unknown 1 |
| Phase 3 | 2 | Completed 2 |
| Phase 1 | 1 | Completed 1 |
Follow Epoprostenol: new trials by email Literature Review of Epoprostenol trials Research Report on Epoprostenol
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Evaluation of a New Thermostable Formulation of FLOLAN in Japanese Subjects FLOLAN injection with currently marketed diluent, FLOLAN injection with reformulated diluent - Cardiovascular Disease | Phase 4 | Completed | GlaxoSmithKline | 10 | 2016-05-01 | 2017-04-06 |
| Nebulized Epoprostenol (FLOLAN) and Phenylephrine on One Lung Ventilation (OLV) Inhaled Epoprostenol and phenylephrine, Sevoflurane, Propofol - Oxygenation During One Lung Ventilation | Phase 4 | Completed | University Health Network, Toronto | 8 | 2016-03-01 | 2019-05-17 |
| Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL) Antithrombin-III, Infliximab, Apotransferrin - Reperfusion Injury | Phase 2 | Completed | Universitaire Ziekenhuizen KU Leuven | 143 | 2014-09-01 | 2024-08-23 |
| Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement Nitric Oxide, Prostacyclin - Heart Failure | Phase 4 | Completed | Stanford University | 14 | 2012-10-01 | 2017-10-09 |
| Vasopressin and Inhaled Prostacyclin in Pediatric Pulmonary Hypertension Vasopressin infusion, Vasopressin infusion and epoprostenol inhalation - Pulmonary Hypertension | Phase 2 | Terminated | University of Alberta | 3 | 2012-02-01 | 2018-12-19 |
| Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH) current marketed FLOLAN (epoprostenol sodium), new thermo stable formulation of epoprostenol sodium - Hypertension, Pulmonary | Phase 4 | Completed | GlaxoSmithKline | 16 | 2011-11-01 | 2017-10-16 |
| Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage Prostacyclin 1 ng/kg/min, Prostacyclin 2 ng/kg/min, Placebo - Subarachnoid Hemorrhage | Phase 2 | Completed | Rune Rasmussen | 90 | 2011-10-01 | 2014-07-21 |
| Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension Epoprostenol - Pulmonary Arterial Hypertension | Phase 3 | Completed | Actelion | 41 | 2011-06-01 | 2025-02-04 |
| Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi - Pulmonary Arterial Hypertension | Completed | Actelion | 797 | 2011-06-01 | 2018-08-15 | |
| Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension EFI/ACT-385781A - Pulmonary Arterial Hypertension | Phase 3 | Completed | Actelion | 42 | 2011-03-01 | 2015-01-13 |
| Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies inhaled prostacyclin, prostacyclin, subcutaneous and intravenous prostacyclin - Pulmonary Arterial Hypertension | Completed | United Therapeutics | 1333 | 2010-12-01 | 2016-02-17 | |
| Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401 ACT-385781A (Actelion Epoprostenol), Flolan® - Pulmonary Arterial Hypertension | Phase 4 | Completed | Actelion | 2 | 2010-05-01 | 2012-12-03 |
| Epoprostenol for Injection in Pulmonary Arterial Hypertension ACT-385781A (Actelion Epoprostenol), Flolan® - Pulmonary Arterial Hypertension | Phase 4 | Completed | Actelion | 30 | 2010-03-01 | 2025-02-04 |
| The Effect of Prostaglandin I2 on the Endothelial Cell Function Disorder in Type 2 Diabetes Mellitus Patients Prostaglandin I2, Placebo - Type 2 Diabetes Mellitus, Peripheral Microvascular Symptoms | Phase 4 | Completed | Yonsei University | 110 | 2010-01-01 | 2016-02-15 |
| Rapid Switch From Flolan to Remodulin in the Outpatient Clinic treprostinil sodium - Hypertension, Pulmonary | Phase 4 | Terminated | United Therapeutics | 7 | 2008-03-01 | 2024-01-03 |
| Prostacyclin's Effect on Platelet Responsiveness prostacyclin, heparin - Acute Kidney Failure | Phase 4 | Completed | Catholic University of the Sacred Heart | 23 | 2007-09-01 | 2009-04-29 |
| Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2 Prostacyclin, PGI2, Placebo - Headache, Migraine | Not applicable | Unknown | Glostrup University Hospital, Copenhagen | 12 | 2006-12-01 | 2007-08-01 |
| Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin treprostinil sodium - Pulmonary Hypertension | Phase 4 | Completed | United Therapeutics | 10 | 2006-09-01 | 2013-01-07 |
| Inhaled Prostacyclin for Adult Respiratory Distress Syndrome (ARDS) and Pulmonary Hypertension PGE1 (prostacyclin), normal saline - Adult Respiratory Distress Syndrome, Pulmonary Hypertension | Not applicable | Completed | Aga Khan University | 67 | 2006-05-01 | 2010-05-19 |
| Epoprostenol in Pulmonary Embolism epoprostenol - Acute Pulmonary Embolism | Phase 4 | Completed | Universitair Ziekenhuis Brussel | 14 | 2004-01-01 | 2009-11-16 |
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Pulmonary Arterial Hypertension (9) · Hypertension, Pulmonary (7) · Cardiovascular Diseases (2) · Acute Kidney Injury (1) · Aneurysm (1) · Brain Injuries, Traumatic (1) · Diabetes Mellitus, Type 2 (1) · Familial Primary Pulmonary Hypertension (1) · Headache (1) · Heart Failure (1) · Hypertension (1) · Migraine Disorders (1) · Pulmonary Embolism (1) · Rare Diseases (1) · Reperfusion Injury (1)
Actelion (5) · GlaxoSmithKline (3) · United Therapeutics (3) · Aga Khan University (1) · Catholic University of the Sacred Heart (1) · Glostrup University Hospital, Copenhagen (1) · National Center for Research Resources (NCRR) (1) · Rune Rasmussen (1) · Stanford University (1) · Umeå University (1) · Universitair Ziekenhuis Brussel (1) · Universitaire Ziekenhuizen KU Leuven (1) · University Health Network, Toronto (1) · University of Alberta (1) · Yonsei University (1)
United States (7) · Canada (4) · Netherlands (3) · Belgium (2) · Denmark (2) · Italy (2) · France (1) · Japan (1) · Puerto Rico (1) · South Korea (1) · Spain (1) · Sweden (1)
Wade Benton, PharmD (2) · Adaani E. Frost (1) · Andrew J Powers, MD (1) · Diethard Monbaliu, MD, PhD (1) · Lars-Owe Koskinen, Professor (1) · Massimo Antonelli, MD (1) · Omar Minai, MD (1) · Professor Dong-Hoon Choi (1) · Rune Rasmussen, MD (1) · Shahla Siddiqui, MBBS, DABA (1) · Troels Wienecke, MD (1) · Vallerie McLaughlin, MD (1) · Victor Tapson, MD (1)
PMID 19226191, PMID 20353588, PMID 22747768, PMID 24600548, PMID 24929796, PMID 25414173, PMID 25518864, PMID 25793960, PMID 27683610, PMID 29608587, PMID 33314078, PMID 34914037, PMID 36853611