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	NCT01332331 (ClinicalTrials.gov)	January 4, 2011	24/3/2011	Efficacy and Safety of Ambrisentan in Children 8-18yrs	A Randomized, Open Label Study Comparing Safety and Efficacy Parameters for a High and a Low Dose of Ambrisentan (Adjusted for Body Weight) for the Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years	Hypertension, Pulmonary	Drug: Ambrisentan - low dose;Drug: Ambrisentan - high dose	GlaxoSmithKline	NULL	Terminated	8 Years	18 Years	All	41	Phase 2	United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Greece;Mexico;Netherlands

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

NCT01332331
(ClinicalTrials.gov)

January 4, 2011

24/3/2011

Efficacy and Safety of Ambrisentan in Children 8-18yrs

A Randomized, Open Label Study Comparing Safety and Efficacy Parameters for a High and a Low Dose of Ambrisentan (Adjusted for Body Weight) for the Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years

Hypertension, Pulmonary

Drug: Ambrisentan - low dose;Drug: Ambrisentan - high dose

GlaxoSmithKline

NULL

Terminated

8 Years

18 Years

All

Phase 2

United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Greece;Mexico;Netherlands