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
86	肺動脈性肺高血圧症	1

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	EUCTR2016-003978-41-Outside-EU/EEA (EUCTR)		13/10/2016	Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension	A Phase 3, Multi-center, Open label Study To Investigate Safety, Efficacy, And Tolerability Of Sildenafil Citrate In Pediatric Patients With Pulmonary Arterial Hypertension	Pulmonary arterial hypertension MedDRA version: 19.0;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: Revatio 10 mg/ml powder for oral suspension Product Name: Revatio POS Product Code: G04BE03 INN or Proposed INN: 171 Other descriptive name: SILDENAFIL CITRATE Trade Name: Revatio 20 mg film coated tablets Product Name: Revatio Tablets Product Code: G04BE03 INN or Proposed INN: 171 Other descriptive name: SILDENAFIL CITRATE	Pfizer, Inc.	NULL	NA			Female: yes Male: yes	6	Phase 3	Japan

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

EUCTR2016-003978-41-Outside-EU/EEA
(EUCTR)

13/10/2016

Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension

A Phase 3, Multi-center, Open label Study To Investigate Safety, Efficacy, And Tolerability Of Sildenafil Citrate In Pediatric Patients With Pulmonary Arterial Hypertension

Pulmonary arterial hypertension
MedDRA version: 19.0;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: Revatio 10 mg/ml powder for oral suspension
Product Name: Revatio POS
Product Code: G04BE03
INN or Proposed INN: 171
Other descriptive name: SILDENAFIL CITRATE
Trade Name: Revatio 20 mg film coated tablets
Product Name: Revatio Tablets
Product Code: G04BE03
INN or Proposed INN: 171
Other descriptive name: SILDENAFIL CITRATE

Pfizer, Inc.

NULL

Female: yes
Male: yes

Phase 3

Japan