294. 先天性横隔膜ヘルニア Congenital diaphragmatic hernia Clinical trials / Disease details
臨床試験数 : 16 / 薬物数 : 26 - (DrugBank : 5) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 14
| 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 | NCT05201144 (ClinicalTrials.gov) | September 15, 2022 | 7/1/2022 | A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH) | A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH) | Congenital Diaphragmatic Hernia;Pulmonary Hypertension | Drug: Sildenafil Oral Suspension;Other: Placebo | University of Utah | NULL | Recruiting | N/A | N/A | All | 40 | Phase 2 | United States |
| 2 | EUCTR2017-000421-13-IT (EUCTR) | 20/03/2020 | 06/10/2020 | Newborns with Congenital diaphragmatic hernia; iNO versus sildenafil | Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS Trial | Congenital diaphragmatic hernia with pulmonary hypertension MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: REVATIO - 0.8 MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 1 FLACONCINO DA 20 ML Product Name: Sildenafil Product Code: [na] INN or Proposed INN: Sildenafil Trade Name: INALOSSIN - 800 PPM MOL/MOL GAS MEDICINALE COMPRESSO BOMBOLA IN ALLUMINIO CON VALVOLA VI DA 20 LITRI Product Name: INALOSSIN 800 PPM MOL/MOL GAS MEDICINALE COMPRESSO Product Code: [na] INN or Proposed INN: OSSIDO DI AZOTO Other descriptive name: Nitric oxide | ERASMUS MEDICAL CENTER | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Spain;Belgium;Austria;Norway;Netherlands;Germany;Italy;Sweden | ||
| 3 | EUCTR2017-000421-13-BE (EUCTR) | 07/02/2019 | 19/02/2019 | Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil. | Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS trial | Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: revatio 0.8mg/ml solution for injection Trade Name: INOmax 800ppm mol/mol inhalatiegas INN or Proposed INN: NITRIC OXIDE Trade Name: Neophyr 1000ppm mol/mol | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belgium;Austria;Netherlands | ||
| 4 | EUCTR2017-000421-13-AT (EUCTR) | 13/07/2018 | 08/05/2018 | Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil. | Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS trial | Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: revatio 0.8mg/ml solution for injection INN or Proposed INN: Sildenafil Trade Name: INOmax 800ppm mol/mol inhalatiegas INN or Proposed INN: NITRIC OXIDE | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 4 | Austria;Netherlands | ||
| 5 | EUCTR2017-000421-13-NL (EUCTR) | 27/07/2017 | 07/06/2017 | Treatment of high blood pressure in the lungs in newborns with a defect inthe diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil. | Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxideversus intravenous Sildenafil:an international randomized controlled trial - CoDiNOS trial | Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: revatio 0.8mg/ml solution for injection Trade Name: INOmax 800ppm mol/mol inhalatiegas | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Belgium;Austria;Norway;Netherlands;Sweden | ||
| 6 | EUCTR2017-000421-13-SE (EUCTR) | 11/09/2018 | Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil. | Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS trial | Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: revatio 0.8mg/ml solution for injection Trade Name: INOmax 800ppm mol/mol inhalatiegas INN or Proposed INN: NITRIC OXIDE | Erasmus MC | NULL | NA | Female: yes Male: yes | 330 | Phase 3 | Belgium;Austria;Norway;Netherlands;Sweden | |||
| 7 | EUCTR2017-000421-13-NO (EUCTR) | 11/01/2018 | Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil. | Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS trial | Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: revatio 0.8mg/ml solution for injection Trade Name: INOmax 800ppm mol/mol inhalatiegas INN or Proposed INN: NITRIC OXIDE Trade Name: Neophyr 1000ppm mol/mol | Erasmus MC | NULL | NA | Female: yes Male: yes | 330 | Phase 3 | Belgium;Austria;Netherlands;Norway |