Clinical Trials List
Protocol NumberAC-055-315
NCT Number(ClinicalTrials.gov Identfier)NCT04273945
Active
2020-05-08 - 2026-12-31
Phase III
Recruiting4
ICD-10I27.0
Primary pulmonary hypertension
ICD-9416.0
Primary pulmonary 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
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Trial Applicant
Johnson & Johnson
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Sponsor
Janssen Research & Development, LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Po-Sheng Chen Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- SHUENN-WEN KUO Division of Thoracic Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Pulmonary Arterial Hypertension
Objectives
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.
Test Drug
JNJ-67896062
Active Ingredient
Macitentan
Dosage Form
film-coated tablet
Dosage
75 mg
Endpoints
Primary Outcome Measures :
Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) Events [ Time Frame: Up to 4 years ]
Time to first CEC-adjudicated M/M event on-treatment (that is up to 7 days after the last dose of double-blind study treatment) is defined as time from baseline to the first of the following events: All-cause death, including deaths caused by an on-treatment adverse event (AE) that occur within 4 weeks of study DB treatment discontinuation; non-planned Pulmonary Arterial Hypertension (PAH)-related hospitalization (including for worsening of PAH, atrial septostomy, lung transplantation with or without heart transplantation, or initiation of parenteral prostacyclins); and PAH-related disease progression, defined as deterioration by at least 15 percent (%) in exercise capacity, as measured by the 6-Minute Walk Distance (6MWD), from baseline, confirmed by two 6MWD tests performed on separate days within 2 weeks of each other and Initiation of additional PAH therapy or Worsening of World Health Organization Functional Class (WHO FC).
Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) Events [ Time Frame: Up to 4 years ]
Time to first CEC-adjudicated M/M event on-treatment (that is up to 7 days after the last dose of double-blind study treatment) is defined as time from baseline to the first of the following events: All-cause death, including deaths caused by an on-treatment adverse event (AE) that occur within 4 weeks of study DB treatment discontinuation; non-planned Pulmonary Arterial Hypertension (PAH)-related hospitalization (including for worsening of PAH, atrial septostomy, lung transplantation with or without heart transplantation, or initiation of parenteral prostacyclins); and PAH-related disease progression, defined as deterioration by at least 15 percent (%) in exercise capacity, as measured by the 6-Minute Walk Distance (6MWD), from baseline, confirmed by two 6MWD tests performed on separate days within 2 weeks of each other and Initiation of additional PAH therapy or Worsening of World Health Organization Functional Class (WHO FC).
Inclution Criteria
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 dyn*sec/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
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 dyn*sec/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
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) > 1.5*upper limit of normal (ULN) at screening
Hemoglobin < 100 gram per liter (g/L) (< 10 gram per deciliter [g/dL]) at screening
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) > 1.5*upper limit of normal (ULN) at screening
Hemoglobin < 100 gram per liter (g/L) (< 10 gram per deciliter [g/dL]) at screening
The Estimated Number of Participants
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Taiwan
12-20 participants
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Global
900 participants
