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	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	JPRN-JapicCTI-121986	01/9/2012	17/10/2012	Macitentan PAH	A multicenter, open-label, phase II/III study to asseses the efficacy, safety and Pharmacokinetics(PK) of macitentan (ACT-064992) in patients with pulmonary arterial hypertension	Pulmonary arterial hypertension (PAH)	Intervention name : ACT-064992 INN of the intervention : macitentan Dosage And administration of the intervention : macitentan tablet 10 mg once daily	Nippon Shinyaku co.,LTD./Actelion Pharmaceuticals Japan Ltd.	NULL		16		BOTH	22	Phase 2;Phase 3	NULL
2	NCT00660179 (ClinicalTrials.gov)	May 2008	14/4/2008	Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension	A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: macitentan (ACT-064992);Drug: placebo	Actelion	NULL	Completed	12 Years	N/A	All	742	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Norway;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Brazil;Czech Republic;Denmark;Finland;Former Serbia and Montenegro;Portugal

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

JPRN-JapicCTI-121986

01/9/2012

17/10/2012

Macitentan PAH

A multicenter, open-label, phase II/III study to asseses the efficacy, safety and Pharmacokinetics(PK) of macitentan (ACT-064992) in patients with pulmonary arterial hypertension

Pulmonary arterial hypertension (PAH)

Intervention name : ACT-064992
INN of the intervention : macitentan
Dosage And administration of the intervention : macitentan tablet 10 mg once daily

Nippon Shinyaku co.,LTD./Actelion Pharmaceuticals Japan Ltd.

NULL

BOTH

Phase 2;Phase 3

NULL

NCT00660179
(ClinicalTrials.gov)

May 2008

14/4/2008

Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

Drug: macitentan (ACT-064992);Drug: placebo

Actelion

NULL

Completed

12 Years

N/A

All

742

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Norway;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Brazil;Czech Republic;Denmark;Finland;Former Serbia and Montenegro;Portugal