86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details
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-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 | ||
| 2 | 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 | |||
| 3 | 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 | |||
| 4 | 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 |
| 5 | 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 | ||
| 6 | 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 | |||
| 7 | 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 | ||
| 8 | 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 | |||
| 9 | 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 | ||
| 10 | 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 |