EPOPROSTENOL ( DrugBank: Epoprostenol )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 86 | 肺動脈性肺高血圧症 | 23 |
86. 肺動脈性肺高血圧症
臨床試験数 : 1,205 / 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-JapicCTI-142722 | 01/1/2015 | 27/11/2014 | ACT-385781A extension study for PAH pediatric patients | Open-label, long-term, efficacy, safety, and tolerability extension study using ACT-385781A in the treatment of Japanese children with pulmonary arterial hypertension who completed the AC-066A308 study. | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-385781A INN of the intervention : epoprostenol Dosage And administration of the intervention : continuous intravenous infusion | Actelion Pharmaceuticals Japan Ltd. | NULL | 14 | BOTH | 3 | Phase 3 | NULL | ||
| 2 | JPRN-JapicCTI-142721 | 01/9/2014 | 27/11/2014 | ACT-385781A for PAH pediatric patients | Prospectiove, single-arm, Open-label, multi-center study to assess the efficacy, safety, and tolerability of ACT-385781A in Japanese children with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-385781A INN of the intervention : epoprostenol Dosage And administration of the intervention : continuous intravenous infusion Control intervention name : null | Actelion Pharmaceuticals Japan Ltd. | NULL | 14 | BOTH | 3 | Phase 3 | NULL | ||
| 3 | JPRN-JapicCTI-132142 | 01/4/2013 | 03/06/2013 | ACT-385781A PAH Post-marketing study | A Post-marketing, Open-label-study ACT-385781A in patients with pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-385781A INN of the intervention : Epoprostenol Dosage And administration of the intervention : A commercially available epoprostenol sodium preparation will be switched to the study drug at the same dose | Actelion Pharmaceuticals Japan Ltd. | NULL | 20 | BOTH | 5 | Phase 4 | NULL | ||
| 4 | EUCTR2010-018320-10-ES (EUCTR) | 26/12/2011 | 21/11/2011 | An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection) | An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH)Extension del estudio AC-066A301, abierta, para investigar la seguridad y la tolerabilidad de ACT-385781A en pacientes con Hipertension Arterial Pulmonar (HAP) - EPITOME-2 Extension | Hipertension Arterial Pulmonar MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Canada;Belgium;Spain;Netherlands;Italy | |||
| 5 | EUCTR2011-002943-92-NL (EUCTR) | 07/11/2011 | 22/08/2011 | Study of a new thermostable formulation of Flolan™ to treat Pulmonary Arterial Hypertension (PAH) | A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN™ in Subjects with Pulmonary Arterial Hypertension (PAH) | pulmonary arterial hypertension (PAH) MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: FLOLAN™ and Glycine Diluent Product Name: FLOLAN™ and Glycine Diluent Product Code: 4AU76 INN or Proposed INN: EPOPROSTENOL Trade Name: FLOLAN TM and Glycine Diluent Product Name: FLOLAN™ and Glycine Diluent Product Code: 4AU76 INN or Proposed INN: EPOPROSTENOL | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 20 | United States;Canada;Netherlands | |||
| 6 | EUCTR2010-018320-10-IT (EUCTR) | 04/11/2011 | 01/03/2012 | An extension of study AC-066A301 to investigate safety and tolerabilityof the study medication (epoprostenol for injection) | Estensione in aperto dello studio AC-066A301 per valutare la sicurezza e la tollerabilita' dell’ACT-385781A nei pazienti affetti da ipertensione arteriosa polmonare (IAP) - EPITOME-2 Extension | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Epoprostenolo per iniezione INN or Proposed INN: EPOPROSTENOL SODIUM Other descriptive name: NA Trade Name: Epoprostenolo per iniezione INN or Proposed INN: EPOPROSTENOL SODIUM | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Canada;Spain;Belgium;Netherlands;Italy | |||
| 7 | NCT01462565 (ClinicalTrials.gov) | November 1, 2011 | 13/10/2011 | Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH) | A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN® in Subjects With Pulmonary Arterial Hypertension (PAH). (FLOLAN® is a Registered Trademark of the GlaxoSmithKline Group of Companies.) | Hypertension, Pulmonary | Drug: current marketed FLOLAN (epoprostenol sodium);Drug: new thermo stable formulation of epoprostenol sodium | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 16 | Phase 4 | United States;Canada;Netherlands |
| 8 | JPRN-JapicCTI-122017 | 01/8/2011 | 03/12/2012 | ACT-385781A PAH | Open-label study ACT-385781A in patients with pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-385781A INN of the intervention : epoprostenol Dosage And administration of the intervention : Continuous intravenous infusion | Actelion Pharmaceuticals Japan Ltd. | NULL | 20 | BOTH | 10 | Phase 3 | NULL | ||
| 9 | EUCTR2010-018322-40-NL (EUCTR) | 11/07/2011 | 19/07/2011 | A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 | A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 | Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | Netherlands;Belgium;France;Spain;Italy | ||
| 10 | EUCTR2010-018320-10-NL (EUCTR) | 11/07/2011 | 12/05/2011 | An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection) | An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Canada;Belgium;Spain;Netherlands;Italy | |||
| 11 | EUCTR2010-018322-40-ES (EUCTR) | 17/06/2011 | 03/11/2011 | Estudio de investigación clínica para evaluar la seguridad de cambiar el Flolan por un nuevo fármaco llamado Epoprostenol-Actelion en pacientes que padecen hipertensión arterial pulmonar | Estudio de fase 3b multicéntrico, de una única rama, abierto para evaluar los efectos de cambiar de Flolan® a ACT-385781A en pacientes con hipertensión arterial pulmonar // A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 | Hipertensión Arterial Pulmonar (HAP) MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODICO Other descriptive name: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODICO Other descriptive name: EPOPROSTENOL SODIUM | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | France;Canada;Belgium;Spain;Netherlands;Italy | ||
| 12 | NCT01470144 (ClinicalTrials.gov) | June 1, 2011 | 28/10/2011 | Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension | An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Epoprostenol | Actelion | Chiltern International Ltd.;Effi-stat | Completed | N/A | N/A | All | 41 | Phase 3 | Belgium;Canada;France;Italy;Netherlands;Spain |
| 13 | EUCTR2010-018322-40-IT (EUCTR) | 04/05/2011 | 05/01/2012 | A clinical research study to evaluate the safety of changing from Flolanto a new drug called Epoprostenol-Actelion in patients suffering frompulmonary arterial hypertension | Uno studio multicentrico, a braccio singolo, in aperto, di fase 3b, per valutare gli effetti del passaggio da Flolan ad ACT 385781A nei pazienti con ipertensione arteriosa polmonare - EPITOME-2 | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Epoprostenolo per iniezione INN or Proposed INN: Epoprostenol Trade Name: Epoprostenol for injection INN or Proposed INN: Epoprostenol | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Canada;Netherlands;Belgium;France;Spain;Italy | |||
| 14 | NCT01431716 (ClinicalTrials.gov) | March 2011 | 7/9/2011 | Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension | A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: EFI/ACT-385781A | Actelion | NULL | Completed | 18 Years | N/A | All | 42 | Phase 3 | Belgium;Canada;France;Italy;Netherlands;Spain |
| 15 | EUCTR2010-018322-40-BE (EUCTR) | 02/07/2010 | 07/04/2010 | A clinical research study to evaluate the safety of changing from Flolan to a new drug called Epoprostenol-Actelion in patients suffering from pulmonary arterial hypertension | A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | France;Canada;Spain;Belgium;Netherlands;Italy | ||
| 16 | EUCTR2010-018320-10-BE (EUCTR) | 02/07/2010 | 13/04/2010 | An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection) | An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Canada;Spain;Belgium;Netherlands;Italy | |||
| 17 | EUCTR2010-018322-40-FR (EUCTR) | 20/05/2010 | 29/03/2010 | A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 | A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 | Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Epoprostenol-Actelion Product Name: Epoprostenol-Actelion Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | France;Spain;Belgium;Netherlands;Italy | ||
| 18 | NCT01105117 (ClinicalTrials.gov) | May 2010 | 15/4/2010 | Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401 | An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan® | Actelion | NULL | Completed | 18 Years | 65 Years | All | 2 | Phase 4 | United States |
| 19 | NCT01105091 (ClinicalTrials.gov) | March 2010 | 15/4/2010 | Epoprostenol for Injection in Pulmonary Arterial Hypertension | A Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan® | Actelion | NULL | Completed | 18 Years | 65 Years | All | 30 | Phase 4 | United States |
| 20 | NCT00643604 (ClinicalTrials.gov) | March 2008 | 20/3/2008 | Rapid Switch From Flolan to Remodulin in the Outpatient Clinic | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment Satisfaction | Hypertension, Pulmonary | Drug: treprostinil sodium | United Therapeutics | NULL | Terminated | 18 Years | 70 Years | All | 7 | Phase 4 | United States |
| 21 | NCT00439946 (ClinicalTrials.gov) | February 2007 | 22/2/2007 | Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension (PAH): Safety, Efficacy and Treatment Satisfaction | Pulmonary Arterial Hypertension | Drug: treprostinil;Device: Crono Five ambulatory pump | United Therapeutics | NULL | Terminated | 18 Years | 65 Years | All | 8 | Phase 4 | United States |
| 22 | NCT00373360 (ClinicalTrials.gov) | September 2006 | 7/9/2006 | Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction | Pulmonary Hypertension | Drug: treprostinil sodium | United Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 10 | Phase 4 | United States |
| 23 | NCT00159861 (ClinicalTrials.gov) | July 2003 | 8/9/2005 | The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH | A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension. | Pulmonary Hypertension | Drug: Sildenafil citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Pfizer | Completed | 16 Years | N/A | All | 267 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Israel;Italy;Netherlands;Spain;United Kingdom;Czech Republic |