DDrare: Database of Drug Development for Rare Diseases

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	2

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	EUCTR2017-000421-13-NL (EUCTR)	27/07/2017	07/06/2017	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	Phase 3	Netherlands
2	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

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

EUCTR2017-000421-13-NL
(EUCTR)

27/07/2017

07/06/2017

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

Phase 3

Netherlands

EUCTR2017-000421-13-NO
(EUCTR)

11/01/2018