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ACTIVE NOT RECRUITING

NCT04273945

PHASE3

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

Sponsor: Actelion

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

935

Start Date

2020-06-30

Completion Date

2029-02-20

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Pulmonary Arterial Hypertension

Interventions

DRUG

Macitentan 10 mg

Participants will receive macitentan 10 mg film-coated tablets orally.

DRUG

Macitentan 37.5 mg

Participants will receive macitentan 37.5 mg film-coated tablets orally.

DRUG

Macitentan 75 mg

Participants will receive macitentan 75 mg film-coated tablets orally.

DRUG

Placebo

Participants will receive matching placebo film-coated tablets orally.

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 small/coincidental cardiac defect with systemic-to-pulmonary shunt (for example atrial septal defect, ventricular septal defect, patent ductus arteriosus, atrioventricular septal defect) which does not account for the elevated pulmonary vascular resistance (PVR) or persistent PAH documented by an Right heart catheterization (RHC) \>= 1 year after simple systemic-to pulmonary shunt repair * PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to screening: Mean pulmonary artery pressure (mPAP) greater than (\>) 20 millimeters of mercury (mm Hg), and; Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) less than or equal to (\<=) 15 mm Hg, 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 (m) and maximum distance of 440m at screening. Participants able to walk more than 440m at screening are eligible if they are in WHO FC III or IV and n-terminal prohormone of brain natriuretic peptide or n-terminal pro B-type natriuretic peptide (NT-proBNP) level is \>=300 nanograms per liter (ng/L) at screening, based on central laboratory results 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 * 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) ) in participants with a known or suspected history of significant lung disease 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

Locations (274)

Mayo Clinic

Phoenix, Arizona, United States

Arizona Pulmonary Specialists, Ltd

Scottsdale, Arizona, United States

Scripps Memorial Hospital

La Jolla, California, United States

USC Keck

Los Angeles, California, United States

Jeffrey S. Sager, MD Medical Corporation

Santa Barbara, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

National Jewish Health

Denver, Colorado, United States

Cleveland Clinic

Weston, Florida, United States

Piedmont Healthcare

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

St. Vincent Medical Group, Inc.

Indianapolis, Indiana, United States

University Of Iowa - Hospitals & Clinics

Iowa City, Iowa, United States

Norton Pulmonary Specialists

Louisville, Kentucky, United States

Louisiana State University

New Orleans, Louisiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Troy Beaumont

Troy, Michigan, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Saint Louis University Academic Pavillion

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Reno Heart Institute

Reno, Nevada, United States

Winthrop University Hospital

Mineola, New York, United States

Mount Sinai

New York, New York, United States

Columbia University

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Duke

Durham, North Carolina, United States

Lindner Clinical Trial Center/Christ Hospital

Cincinnati, Ohio, United States

Integris Baptist Office

Oklahoma City, Oklahoma, United States

The Oregon Clinic Pulmonary West

Beaverton, Oregon, United States

The Oregon Clinic

Portland, Oregon, United States

Oregon Health And Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Allegheny General Hospital of Research

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

AnMed Health

Anderson, South Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine (BCM) - Baylor Heart Clinic

Houston, Texas, United States

Baylor Scott White - Plano

Plano, Texas, United States

San Antonio Methodist TX Transplant Physicians Group

San Antonio, Texas, United States

The Robert Larner, M.D. College of Medicine at The University of Vermont

Burlington, Vermont, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Medical College Of Wisconsin

Milwaukee, Wisconsin, United States

Sanatorio de la Trinidad Mitre

Buenos Aires, Argentina

Sanatorio Guemes

C.a.b.a., Argentina

Hospital Italiano de Buenos Aires

Caba, Argentina

Sanatorio Ramon Cereijo

Caba, Argentina

Centro Médico Dra. De Salvo

Caba, Argentina

Instituto de Cardiologia de Corrientes

Corrientes, Argentina

Instituto Medico de La Fundacion Estudios Clinicos

Rosario, Argentina

Instituto Cardiovascular de Rosario

Rosario, Argentina

Flinders Medical Centre

Bedford Park, Australia

Royal Prince Alfred Hospital

Camperdown, Australia

The Prince Charles Hospital

Chermside, Australia

St Vincent's hospital

Darlinghurst, Australia

Royal Hobart Hospital

Hobart, Australia

Fiona Stanley Hospital

Murdoch, Australia

Westmead Hospital

Westmead, Australia

LKH-Univ. Klinikum Graz

Graz, Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria

Medical University Vienna

Vienna, Austria

The Republican Scientific-Practical Center ''Cardiology''

Minsk, Belarus

Minsk Regional Clinical Hospital

Minsk, Belarus

ULB Hôpital Erasme

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, Brazil

Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

Belo Horizonte, Brazil

Empresa Brasileira de Servicos Hospitalares-EBSERH-Hospital Universitario de Brasilia

Brasília, Brazil

Sociedade Hospitalar Angelina Caron - Hospital Angelina Caron

Campina Grande do Sul, Brazil

Ceti - Centro de Estudos Em Terapias Inovadoras

Curitiba, Brazil

Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina

Florianópolis, Brazil

Hospital das Clinicas - UFG

Goiânia, Brazil

Hospital De Clinicas De Porto Alegre

Porto Alegre, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, Brazil

Cepes - Fmabc

São Paulo, Brazil

Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

Sofia, Bulgaria

St. Joseph's Health Centre

Hamilton, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Beijing Chaoyang Hospital

Beijing, China

Beijing Anzhen Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

The Second Xiangya Hospital of Central South Hospital

Changsha, China

West China Hospital Sichuan University

Chengdu, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Shanghai Pulmonary Hospital

Shanghai, China

Renji Hospital

Shanghai, China

Zhongshan Hospital Fudan University

Shanghai, China

The General Hospital of Northern Theater Command

Shenyang, China

Shengjing Hospital Of China Medical University

Shenyang, China

Tianjin Medical University General Hospital

Tianjin, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Fundacion Neumologica Colombiana

Bogotá, Colombia

Fundacion Cardiovascular de Colombia

Bucaramanga - Piedecuesta - Valle de Menzuli, Colombia

And 174 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (274)