INOmax 800ppm mol/mol inhalatiegas ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
294先天性横隔膜ヘルニア5

294. 先天性横隔膜ヘルニア


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-000421-13-BE
(EUCTR)
07/02/201919/02/2019Treatment 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 MCNULLAuthorised-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): noBelgium;Austria;Netherlands
2EUCTR2017-000421-13-AT
(EUCTR)
13/07/201808/05/2018Treatment 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 MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
330Phase 4Austria;Netherlands
3EUCTR2017-000421-13-NL
(EUCTR)
27/07/201707/06/2017Treatment 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 MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Belgium;Austria;Norway;Netherlands;Sweden
4EUCTR2017-000421-13-NO
(EUCTR)
11/01/2018Treatment 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 MCNULLNAFemale: yes
Male: yes
330Phase 3Belgium;Austria;Netherlands;Norway
5EUCTR2017-000421-13-SE
(EUCTR)
11/09/2018Treatment 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 MCNULLNAFemale: yes
Male: yes
330Phase 3Belgium;Austria;Norway;Netherlands;Sweden