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
Updated on 2 December 2020
Investigator
The Medical Research Network, LLC
Primary Contact
CHU Saint-Etienne - H pital Nord (0.0 mi away) Contact
+225 other location
hypertension
heart disease
connective tissue disease
ventricular septal defect
macitentan
right heart catheterization
septal defect
left ventricular end-diastolic pressure
macitentan 10 mg
hemodynamic evaluation

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
Treatment Placebo, Macitentan 10 mg, Macitentan 37.5 mg, Macitentan 75 mg
Clinical Study IdentifierNCT04273945
SponsorActelion
Last Modified on2 December 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Pulmonary Arterial Hypertension?
Do you have any of these conditions: Do you have Pulmonary Arterial Hypertension??
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) as documented by a spirometry test performed within 1 year 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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