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	NCT04273945 (ClinicalTrials.gov)	June 30, 2020	31/1/2020	Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg	Pulmonary Arterial Hypertension	Drug: Macitentan 10 mg;Drug: Macitentan 37.5 mg;Drug: Macitentan 75 mg;Drug: Placebo	Actelion	NULL	Recruiting	18 Years	N/A	All	900	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Vietnam;Romania

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

NCT04273945
(ClinicalTrials.gov)

June 30, 2020

31/1/2020

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension

A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg

Pulmonary Arterial Hypertension

Drug: Macitentan 10 mg;Drug: Macitentan 37.5 mg;Drug: Macitentan 75 mg;Drug: Placebo

Actelion

NULL

Recruiting

18 Years

N/A

All

900

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Vietnam;Romania