INOmax ( DrugBank: - )

3 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
85	特発性間質性肺炎	1
294	先天性横隔膜ヘルニア	5
299	嚢胞性線維症	1

85. 特発性間質性肺炎

臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212

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	EUCTR2014-003423-21-BE (EUCTR)	29/09/2014	29/08/2014	Evaluation of impact of inhaled nitric oxide on pulmonary vessel blood volume measured by high resolution computed tomography (HRCT) in subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in subjects with WHO Group 3 Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF) on Long-Term Oxygen Therapy (LTOT) (Part 2).	An Exploratory, Two-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic pulmonary fibrosis (IPF) on LTOT (Part 2).	Part 1: Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) Part 2: Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 18.1;Level: LLT;Classification code 10010952;Term: COPD;Classification code 10009033;Term: Chronic obstructive pulmonary disease;Classification code 10037400;Term: Pulmonary hypertension;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: INOmax 400ppm mol/mol inhalation gas Product Name: INO INN or Proposed INN: NITRIC OXIDE	Bellerophon Pulse Technologies LLC	NULL	Not Recruiting			Female: yes Male: yes		Phase 1;Phase 2	Belgium

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.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Phase	Countries
1	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
2	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
3	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
4	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
5	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

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299. 嚢胞性線維症

臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174

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	EUCTR2010-023529-39-GB (EUCTR)	18/02/2011	31/12/2010	Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0	Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0	Cystic Fibrosis	Trade Name: INOmax 400ppm mol/mol inhalation gas Product Name: Nitric Oxide Product Code: NO	Southampton University Hopsitals NHS Trust	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	United Kingdom

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