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	EUCTR2010-019547-19-Outside-EU/EEA (EUCTR)		16/03/2012	Testing medicines to treat children with pulmonary arterial hypertension(PAH)	A randomized, open label study comparing safety and efficacyparameters for a high and a low dose of ambrisentan (adjustedfor body weight) for the treatment of pulmonary arterialhypertension in paediatric patients aged 8 years up to 18 years. - Efficacy and Safety of Ambrisentan in Children 8-17yrs	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: VOLIBRIS Trade Name: VOLIBRIS™ tablets Product Name: Ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: VOLIBRIS Trade Name: VOLIBRIS™ tablets Product Name: Ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: VOLIBRIS	GlaxoSmithKline Research & Development Limited	NULL	NA			Female: yes Male: yes	66		Russian Federation;United States;Argentina;Brazil;Canada;Japan;Mexico

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

EUCTR2010-019547-19-Outside-EU/EEA
(EUCTR)

16/03/2012

Testing medicines to treat children with pulmonary arterial hypertension(PAH)

A randomized, open label study comparing safety and efficacyparameters for a high and a low dose of ambrisentan (adjustedfor body weight) for the treatment of pulmonary arterialhypertension in paediatric patients aged 8 years up to 18 years. - Efficacy and Safety of Ambrisentan in Children 8-17yrs

Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: VOLIBRIS
Trade Name: VOLIBRIS™ tablets
Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: VOLIBRIS
Trade Name: VOLIBRIS™ tablets
Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: VOLIBRIS

GlaxoSmithKline Research & Development Limited

NULL

Female: yes
Male: yes

Russian Federation;United States;Argentina;Brazil;Canada;Japan;Mexico