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

STATUS

Recruiting
End date

Aug 21, 2026
participants needed

900
sponsor

Actelion

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Updated on 19 February 2024

See if I qualify

HIV Infection

heart disease

hypertension

left ventricular end-diastolic pressure

macitentan 10 mg

right heart catheterization

connective tissue disease

patent ductus arteriosus

macitentan

septal defect

ventricular septal defect

hemodynamic evaluation

atrial septal defect

ventricular septal defects

Summary

The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.

Details

Condition	Pulmonary Arterial Hypertension
Age	18years - 100years
Treatment	Placebo, Macitentan 10 mg, Macitentan 37.5 mg, Macitentan 75 mg
Clinical Study Identifier	NCT04273945
Sponsor	Actelion
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Target population: greater than or equal to (>=) 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age
	Target population: Symptomatic Pulmonary Arterial Hypertension (PAH) in World Health Organization Functional Class (WHO FC) II, III, or IV
	Target population: PAH subtype falling in one of the below classifications: Idiopathic; Heritable; Drug- or toxin-induced; Related to: Connective tissue disease, HIV infection, Portal hypertension, and Congenital heart disease with simple systemic-to-pulmonary shunt (atrial septal defect, ventricular septal defect, patent ductus arteriosus) with persistent PH documented by an Right heart catheterization (RHC) >= 1 year after surgical repair
	PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to screening: Mean pulmonary artery pressure (mPAP) > 20 millimeters of mercury (mmHg), and; Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) less than or equal to (<=) 15 mmHg, and PVR >= 3 Wood Units (that is, >= 240 dynsec/cm^5)
	Able to perform the 6-minute walking test (6MWT) with a minimum distance of 50 meters and maximum distance of 440 meters at screening
Exclusion Criteria
	Known presence of three or more of the following risk factors for heart failure with preserved ejection fraction at screening, based on records that confirm documented medical history: Body mass index (BMI) > 30 kilograms per meter square (kg/m^2), Diabetes mellitus of any type, Essential hypertension (even if well controlled); Coronary artery disease, that is, any of the following: history of stable angina, or known more than 50 percent (%) stenosis in a coronary artery, or history of myocardial infarction, or history of or planned coronary artery bypass grafting and/or coronary artery stenting
	Known presence of moderate or severe obstructive lung disease (forced expiratory volume in 1 second [FEV1] / forced vital capacity [FVC] < 70%; and FEV1 < 60% of predicted after bronchodilator administration) at any time prior to screening
	Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based on records that confirm documented medical history
	Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5upper limit of normal (ULN) at screening
	Hemoglobin < 100 gram per liter (g/L) (< 10 gram per deciliter [g/dL]) at screening

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heart disease

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macitentan 10 mg

right heart catheterization

connective tissue disease

patent ductus arteriosus

macitentan

septal defect

ventricular septal defect

hemodynamic evaluation

atrial septal defect

ventricular septal defects

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