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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Macitentan 10 mg
Macitentan 37.5 mg
Macitentan 75 mg
Placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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
  • 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

Sites / Locations

  • Arizona Pulmonary Specialists, LtdRecruiting
  • Mayo ClinicRecruiting
  • Scripps Memorial HospitalRecruiting
  • USC KeckRecruiting
  • Jeffrey S. Sager, MD Medical CorporationRecruiting
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterRecruiting
  • National Jewish HealthRecruiting
  • Cleveland ClinicRecruiting
  • Northside HospitalRecruiting
  • Piedmont HealthcareRecruiting
  • Advocate Christ Medical CenterRecruiting
  • Indiana University
  • St. Vincent Medical Group, Inc.Recruiting
  • University Of Iowa - Hospitals & ClinicsRecruiting
  • Norton Pulmonary SpecialistsRecruiting
  • Louisiana State UniversityRecruiting
  • University of MichiganRecruiting
  • Troy BeaumontRecruiting
  • Washington University School of MedicineRecruiting
  • Saint Louis University Academic PavillionRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Reno Heart InstituteRecruiting
  • Winthrop University HospitalRecruiting
  • Mount SinaiRecruiting
  • Columbia UniversityRecruiting
  • Stony Brook University Medical CenterRecruiting
  • DukeRecruiting
  • Lindner Clinical Trial Center/Christ HospitalRecruiting
  • Integris Baptist OfficeRecruiting
  • The Oregon ClinicRecruiting
  • Oregon Pulmonary ClinicRecruiting
  • Oregon Health & Science UniversityRecruiting
  • University of PennsylvaniaRecruiting
  • Allegheny General Hospital of ResearchRecruiting
  • Lankenau Medical Center
  • AnMed HealthRecruiting
  • UT Southwestern Medical CenterRecruiting
  • Baylor College of Medicine (BCM) - Baylor Heart ClinicRecruiting
  • Baylor Scott White - PlanoRecruiting
  • San Antonio Methodist/TX Transplant Physicians GroupRecruiting
  • The Robert Larner, M.D. College of Medicine at The University of VermontRecruiting
  • University of Wisconsin Hospital and ClinicsRecruiting
  • Medical College Of WisconsinRecruiting
  • Sanatorio de la Trinidad MitreRecruiting
  • Sanatorio GuemesRecruiting
  • Hospital Italiano de Buenos AiresRecruiting
  • Sanatorio Ramon Cereijo
  • Centro Médico Dra. De SalvoRecruiting
  • Instituto de Cardiologia de CorrientesRecruiting
  • Instituto Medico de La Fundacion Estudios ClinicosRecruiting
  • Instituto Cardiovascular de RosarioRecruiting
  • Flinders Medical CentreRecruiting
  • Royal Prince Alfred HospitalRecruiting
  • The Prince Charles HospitalRecruiting
  • St Vincent's hospitalRecruiting
  • Royal Hobart HospitalRecruiting
  • Fiona Stanley HospitalRecruiting
  • Westmead HospitalRecruiting
  • LKH-Univ. Klinikum GrazRecruiting
  • Ordensklinikum Linz GmbH ElisabethinenRecruiting
  • Medical University ViennaRecruiting
  • The Republican Scientific-Practical Center ''Cardiology''
  • Minsk Regional Clinical Hospital
  • ULB Hôpital ErasmeRecruiting
  • UZ LeuvenRecruiting
  • Universidade Federal De Minas Gerais - Hospital das ClínicasRecruiting
  • Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre TeresaRecruiting
  • Ceti - Centro de Estudos Em Terapias InovadorasRecruiting
  • Ynova Pesquisa ClinicaRecruiting
  • Universidade Federal de Goias - Hospital das Clinicas da UFGRecruiting
  • Hospital das Clinicas de Porto AlegreRecruiting
  • Instituto de Medicina Integral Professor Fernando FigueiraRecruiting
  • Fundacao do ABC - Centro Universitario FMABCRecruiting
  • Secretaria de Estado da Saúde - Instituto Dante Pazzanese de CardiologiaRecruiting
  • Hospital Das Clinicas Da Faculdade De Medicina Da USPRecruiting
  • Multiprofile Hospital For Active Treatment National Cardiology Hospital, EadRecruiting
  • University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna ADRecruiting
  • St. Joseph's Health CentreRecruiting
  • University of Ottawa Heart InstituteRecruiting
  • University Health Network - Toronto General HospitalRecruiting
  • Jewish General HospitalRecruiting
  • Beijing Chaoyang HospitalRecruiting
  • Beijing Anzhen HospitalRecruiting
  • Peking Union Medical College HospitalRecruiting
  • The Second Xiangya Hospital of Central South HospitalRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Shanghai Pulmonary HospitalRecruiting
  • Renji HospitalRecruiting
  • Zhongshan Hospital,Fudan UniversityRecruiting
  • The General Hospital of Northern Theater CommandRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Fundacion Neumologica ColombianaRecruiting
  • Fundacion Cardiovascular de ColombiaRecruiting
  • Clínica Imbanaco S.A.S.Recruiting
  • Centro Cardiovascular Colombiano Clínica Santa MaríaRecruiting
  • Hospital Universidad del NorteRecruiting
  • General University Hospital II.department of Internal Medicine-cardiology and angiologyRecruiting
  • Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling BRecruiting
  • CHU de Brest - Hôpital de la Cavale Blanche
  • Hôpital Côte de NacreRecruiting
  • Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-SudRecruiting
  • CHRU de Lille - Hopital Claude Huriez
  • Aphm - Hopital Nord
  • Centre Hospitalier Universitaire - de Nice - Hopital PasteurRecruiting
  • CHU Saint-Etienne - Hôpital NordRecruiting
  • Hopital Larrey CHU de ToulouseRecruiting
  • Ruhr-Universität Bochum / Diabeteszentrum
  • Medizinische Hochschule HannoverRecruiting
  • Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMURecruiting
  • Universitaetsklinikum RegensburgRecruiting
  • University Hospital of AlexandroupolisRecruiting
  • Alexandra General Hospital of AthensRecruiting
  • University Hospital Of LarissaRecruiting
  • Ahepa University General Hospital of ThessalonikiRecruiting
  • Semmelweis Egyetem,Pulmonológiai KlinikaRecruiting
  • Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztályRecruiting
  • Pecsi Tudomanyegyetem Klinikai KozpontRecruiting
  • Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelőRecruiting
  • NHL Medical College (SVP Hospital IMSR)Recruiting
  • Cims HospitalRecruiting
  • Narayana Hrudayalaya LimitedRecruiting
  • SRM Medical College Hospital & Research CentreRecruiting
  • Govindaswamy Kuppuswamy Naidu Memorial HospitalRecruiting
  • HealthWorld HospitalsRecruiting
  • Care HospitalsRecruiting
  • Rabindranath Tagore International Institute of Cardiac SciencesRecruiting
  • GB Pant Institute of Post Graduate Medical Education & ResearchRecruiting
  • Sir Ganga Ram HospitalRecruiting
  • B.D. Mehta Mahavir Heart InstituteRecruiting
  • Carmel Medical Center
  • Shaare Zedek Medical CenterRecruiting
  • Kaplan Medical CenterRecruiting
  • The Chaim Sheba Medical CenterRecruiting
  • Yitzhak Shamir Medical CenterRecruiting
  • ASST Grande Ospedale Metropolitano NiguardaRecruiting
  • AOU Di Modena, Policlinico Di ModenaRecruiting
  • Ospedale San Francesco
  • Fondazione IRCCS Policlinico San MatteoRecruiting
  • Fondazione Toscana Gabriele Monasterio CNRRecruiting
  • Policlinico Gemelli Universita CattolicaRecruiting
  • The University of Tokyo HospitalRecruiting
  • Kyushu University HospitalRecruiting
  • Kure Kyosai HospitalRecruiting
  • Kagoshima University HospitalRecruiting
  • St.Marianna University HospitalRecruiting
  • Kanazawa University HospitalRecruiting
  • Kobe University HospitalRecruiting
  • Kurume University HospitalRecruiting
  • University Hospital Kyoto Perfectural University of MedicineRecruiting
  • Kyoto University HospitalRecruiting
  • Shinshu University HospitalRecruiting
  • Nagasaki University HospitalRecruiting
  • Nagoya University HospitalRecruiting
  • Nagoya City University HospitalRecruiting
  • Niigata University Medical & Dental HospitalRecruiting
  • Okayama University HospitalRecruiting
  • National Hospital Organization Okayama Medical CenterRecruiting
  • Hokkaido University HospitalRecruiting
  • Sapporo Medical University HospitalRecruiting
  • National Cerebral and Cardiovascular CenterRecruiting
  • Juntendo University HospitalRecruiting
  • Fujita Health University HospitalRecruiting
  • University of Tsukuba HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Hospital Pulau PinangRecruiting
  • Hospital SerdangRecruiting
  • Sarawak Heart CenterRecruiting
  • Institut Jantung Negara (National Heart Institute)Recruiting
  • Instituto Nacional de Cardiologia Dr. Ignacio ChavezRecruiting
  • Consultorio Privado del Dr. Gabriel Arturo Ramos LopezRecruiting
  • Operadora de Hospitales Angeles SA de CV Hospital Angeles LomasRecruiting
  • Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'Recruiting
  • Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)Recruiting
  • Centro de Investigacion Clinica ChapultepecRecruiting
  • VUMC AmsterdamRecruiting
  • St. Antonius Ziekenhuis NieuwegeinRecruiting
  • Radboud UmcnRecruiting
  • Erasmus MC
  • Akershus Universitetssykehus
  • Oslo University Hospital
  • Uniwersytecki Szpital Kliniczny w BiałymstokuRecruiting
  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
  • Uniwersyteckie Centrum KliniczneRecruiting
  • SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im. Prof. Leszka GiecaRecruiting
  • Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i NaczynRecruiting
  • Samodzielny Publiczny Szpital Kliniczny nr 2 PUMRecruiting
  • Centralny Szpital Kliniczny MSWiA w WarszawieRecruiting
  • Wojewodzki Szpital Specjalist, Osrodek Badawczo-Rozwojowy
  • Centro Hospitalar e Universitário de Coimbra - Hospitais da Universidade de CoimbraRecruiting
  • Centro Hospitalar Lisboa Norte EPE - Hospital Pulido ValenteRecruiting
  • Hospital De Santa MartaRecruiting
  • Altay Regional Cardiological Dispensary
  • Chelyabinsk Regional Clinical Hospital
  • State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'
  • Scientific and Research Institution of Cardiovascular Diseases Complex Problems
  • Moscow City Clinical Hospital No.51
  • National Medical Research Center of Cardiology of MoH of Russian Federation
  • National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation
  • Samara Regional Clinical Cardiological Dispensary
  • State Autonomous Healthcare Institution of Tyumen Region 'Scientific and Practical Medical Center'
  • Volgograd Regional Clinical Cardiology Center
  • King Faisal Specialist Hospital & Research CenterRecruiting
  • King Fahad Medical CityRecruiting
  • University Clinical Center of SerbiaRecruiting
  • Institute for Pulmonary Disease of VojvodinaRecruiting
  • National University Heart Centre, SingaporeRecruiting
  • National Heart Centre (NHC) SingaporeRecruiting
  • Narodny ustav srdcovych a cievnych chorobRecruiting
  • The Eastern Slovakia Institute of Cardiovascular DiseasesRecruiting
  • Milpark HospitalRecruiting
  • Dr KallaRecruiting
  • Hosp. Univ. Vall D HebronRecruiting
  • Hosp. Del Mar
  • Hosp. Univ. 12 de OctubreRecruiting
  • Hosp. Univ. La PazRecruiting
  • Hosp. Univ. Pta. de Hierro MajadahondaRecruiting
  • Hosp. Costa Del SolRecruiting
  • Hosp. Clinico Univ. de SalamancaRecruiting
  • Sahlgrenska UniversitetsjukhusetRecruiting
  • Skanes universitetssjukhusRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Mackay Memorial HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Phramongkutklao Hospital and Medical CollegeRecruiting
  • Ramathibodi Hospital, Mahidol UniversityRecruiting
  • Siriraj Hospital Mahidol UniversityRecruiting
  • Maharaj Nakorn Chiang Mai hospital - Faculty of MedicineRecruiting
  • Srinagarind Hospital, Khon Kaen UniversityRecruiting
  • Songklanagarind hospitalRecruiting
  • Adana City HospitalRecruiting
  • Cukurova University Medical Faculty
  • Hacettepe University Medical FacultyRecruiting
  • Gazi University Medical FacultyRecruiting
  • Ankara Bilkent Sehir HastanesiRecruiting
  • Akdeniz University Medical FacultyRecruiting
  • Bursa Yuksek Ihtisas Training and Research HospitalRecruiting
  • Pamukkale University Medical FacultyRecruiting
  • Siyami Ersek Training and Research HospitalRecruiting
  • Marmara University Medical FacultyRecruiting
  • Ege University Medical FacultyRecruiting
  • Tepecik Training and Research HospitalRecruiting
  • Dokuz Eylul University Medical FacultyRecruiting
  • Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma HastanesiRecruiting
  • Mersin University Medical FacultyRecruiting
  • CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
  • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
  • MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'
  • CNE' City Clinical Hospital #8' of Kharkiv City Council
  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
  • State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
  • Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
  • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
  • Royal Free HospitalRecruiting
  • Freeman HospitalRecruiting
  • Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire HospitalRecruiting
  • Hanoi Medical University HospitalRecruiting
  • Cho Ray HospitalRecruiting
  • Tam Anh HospitalRecruiting
  • Tam Duc Heart HospitalRecruiting
  • University Medical Center Ho Chi Minh cityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Macitentan 10 milligrams (mg) + Placebo

Macitentan 75 mg + Placebo

Arm Description

Run-in period:Participants who are either endothelin receptor antagonist (ERA)-naïve or who are receiving daily dose of macitentan or ambrisentan less (<) 10 milligrams (mg), or daily dose of bosentan <250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated participants will bypass run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.Double-blind Treatment (DBT) Period:Participants will receive macitentan 10 mg orally up to End of DBT.To maintain blind, participants will receive macitentan 37.5 mg-matching placebo for 4 weeks and macitentan 75 mg-matching placebo thereafter up to DBT.Treatment Extension Period:After EDBT, participants will receive macitentan 37.5 mg once a day (qd) orally for 4 weeks, prior to receiving open-label macitentan 75 mg qd orally for 2 years. To maintain blind, participants will receive macitentan 75 mg-matching placebo during 4-week uptitration.

Run-in period:Participants who are either ERA-naive or who are receiving a daily dose of macitentan or ambrisentan <10 mg, or a daily dose of bosentan <250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated patients will bypass the run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.DBT Period: participants will receive macitentan 37.5 mg orally for 4 weeks and macitentan 75 mg thereafter up to End of DBT. To maintain the blind, participants will receive macitentan 10 mg-matching placebo up to End of DBT.Treatment Extension Period: After EDBT, participants will continue to receive macitentan 75 mg orally for 2 years. To maintain the blind, participants will receive macitentan 37.5 mg-matching placebo during the 4-week up-titration period.

Outcomes

Primary Outcome Measures

Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) Events
Time to first CEC-adjudicated M/M event on-treatment (ie.,up to 7 days after last dose of DB study intervention) is defined as time from randomization to first of following events: All-cause death, including death caused by on-treatment adverse event 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);PAH-related disease progression, defined as worsening of World Health Organization(WHO) Functional Class(FC) from baseline or deterioration by at least 15% in exercise capacity, as measured by 6-minute walk distance(6MWD), from baseline and confirmed by second 6MWD test performed on different day within 2 week of initial test or appearance or worsening of signs or symptoms of right-sided heart failure that require initiation of intravenous diuretics.

Secondary Outcome Measures

Double-blind Treatment Period: Change From Baseline to Week 24 in 6MWD
The 6MWT is a non-encouraged test performed to quantify exercise tolerance and capacity. This standardized test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Double-blind Treatment Period: Number of Participants with CEC-adjudicated Death due to PAH and/or Hospitalizations for PAH (First and Recurrent) Events on-treatment
Number of Participants with CEC-adjudicated death or hospitalization due to PAH will be reported.
Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiopulmonary Symptom Domain Score
The Cardiopulmonary Symptoms domain consists of 6 items reported on a 5-point Likert scale (from 0 to 4). The value 0 means "no symptom" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH symptoms and impact questionnaire (PAH-SYMPACT) is completed daily for a 7-day period. The recall period of symptom items is the last 24 hours. An average Cardiopulmonary Symptoms domain score is determined based on the daily scores of the 6 items.
Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiovascular Symptom Domain Score
The Cardiovascular Symptoms domain consists of 5 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "no symptoms" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH-SYMPACT is completed daily for a 7 day period. The recall period of symptom items is the last 24 hours. An average cardiovascular symptoms domain score is determined based on the daily scores of the 5 items.
Double-blind Treatment Period: Time to Death Occurring Between Randomization and End of Double-blind Treatment (EDBT)
Time to death occurring between randomization and EDBT will be reported.
Treatment Extension Period: Time to Death Occurring Between Randomization and End of Study (EOS)
Time to death occurring between randomization and EOS will be reported.

Full Information

First Posted
January 31, 2020
Last Updated
October 10, 2023
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT04273945
Brief Title
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
Acronym
UNISUS
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
August 27, 2025 (Anticipated)
Study Completion Date
September 21, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Macitentan 10 milligrams (mg) + Placebo
Arm Type
Active Comparator
Arm Description
Run-in period:Participants who are either endothelin receptor antagonist (ERA)-naïve or who are receiving daily dose of macitentan or ambrisentan less (<) 10 milligrams (mg), or daily dose of bosentan <250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated participants will bypass run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.Double-blind Treatment (DBT) Period:Participants will receive macitentan 10 mg orally up to End of DBT.To maintain blind, participants will receive macitentan 37.5 mg-matching placebo for 4 weeks and macitentan 75 mg-matching placebo thereafter up to DBT.Treatment Extension Period:After EDBT, participants will receive macitentan 37.5 mg once a day (qd) orally for 4 weeks, prior to receiving open-label macitentan 75 mg qd orally for 2 years. To maintain blind, participants will receive macitentan 75 mg-matching placebo during 4-week uptitration.
Arm Title
Macitentan 75 mg + Placebo
Arm Type
Experimental
Arm Description
Run-in period:Participants who are either ERA-naive or who are receiving a daily dose of macitentan or ambrisentan <10 mg, or a daily dose of bosentan <250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated patients will bypass the run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.DBT Period: participants will receive macitentan 37.5 mg orally for 4 weeks and macitentan 75 mg thereafter up to End of DBT. To maintain the blind, participants will receive macitentan 10 mg-matching placebo up to End of DBT.Treatment Extension Period: After EDBT, participants will continue to receive macitentan 75 mg orally for 2 years. To maintain the blind, participants will receive macitentan 37.5 mg-matching placebo during the 4-week up-titration period.
Intervention Type
Drug
Intervention Name(s)
Macitentan 10 mg
Other Intervention Name(s)
JNJ-67896062
Intervention Description
Participants will receive macitentan 10 mg film-coated tablets orally.
Intervention Type
Drug
Intervention Name(s)
Macitentan 37.5 mg
Other Intervention Name(s)
JNJ-67896062
Intervention Description
Participants will receive macitentan 37.5 mg film-coated tablets orally.
Intervention Type
Drug
Intervention Name(s)
Macitentan 75 mg
Other Intervention Name(s)
JNJ-67896062
Intervention Description
Participants will receive macitentan 75 mg film-coated tablets orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo film-coated tablets orally.
Primary Outcome Measure Information:
Title
Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) Events
Description
Time to first CEC-adjudicated M/M event on-treatment (ie.,up to 7 days after last dose of DB study intervention) is defined as time from randomization to first of following events: All-cause death, including death caused by on-treatment adverse event 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);PAH-related disease progression, defined as worsening of World Health Organization(WHO) Functional Class(FC) from baseline or deterioration by at least 15% in exercise capacity, as measured by 6-minute walk distance(6MWD), from baseline and confirmed by second 6MWD test performed on different day within 2 week of initial test or appearance or worsening of signs or symptoms of right-sided heart failure that require initiation of intravenous diuretics.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Double-blind Treatment Period: Change From Baseline to Week 24 in 6MWD
Description
The 6MWT is a non-encouraged test performed to quantify exercise tolerance and capacity. This standardized test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Time Frame
Baseline up to Week 24
Title
Double-blind Treatment Period: Number of Participants with CEC-adjudicated Death due to PAH and/or Hospitalizations for PAH (First and Recurrent) Events on-treatment
Description
Number of Participants with CEC-adjudicated death or hospitalization due to PAH will be reported.
Time Frame
Up to 4 years
Title
Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiopulmonary Symptom Domain Score
Description
The Cardiopulmonary Symptoms domain consists of 6 items reported on a 5-point Likert scale (from 0 to 4). The value 0 means "no symptom" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH symptoms and impact questionnaire (PAH-SYMPACT) is completed daily for a 7-day period. The recall period of symptom items is the last 24 hours. An average Cardiopulmonary Symptoms domain score is determined based on the daily scores of the 6 items.
Time Frame
Baseline up to Week 24
Title
Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiovascular Symptom Domain Score
Description
The Cardiovascular Symptoms domain consists of 5 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "no symptoms" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH-SYMPACT is completed daily for a 7 day period. The recall period of symptom items is the last 24 hours. An average cardiovascular symptoms domain score is determined based on the daily scores of the 5 items.
Time Frame
Baseline up to Week 24
Title
Double-blind Treatment Period: Time to Death Occurring Between Randomization and End of Double-blind Treatment (EDBT)
Description
Time to death occurring between randomization and EDBT will be reported.
Time Frame
Up to 4 years
Title
Treatment Extension Period: Time to Death Occurring Between Randomization and End of Study (EOS)
Description
Time to death occurring between randomization and EOS will be reported.
Time Frame
Up to 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Actelion Clinical Trials
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Pulmonary Specialists, Ltd
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
Scripps Memorial Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
USC Keck
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Jeffrey S. Sager, MD Medical Corporation
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Recruiting
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502-2006
Country
United States
Individual Site Status
Recruiting
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Weston
State/Province
Florida
ZIP/Postal Code
33331-3609
Country
United States
Individual Site Status
Recruiting
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Healthcare
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Individual Site Status
Recruiting
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Completed
Facility Name
St. Vincent Medical Group, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Name
University Of Iowa - Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Pulmonary Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Louisiana State University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-7021
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5000
Country
United States
Individual Site Status
Recruiting
Facility Name
Troy Beaumont
City
Troy
State/Province
Michigan
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1032
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Louis University Academic Pavillion
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2265
Country
United States
Individual Site Status
Recruiting
Facility Name
Reno Heart Institute
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Individual Site Status
Recruiting
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-4000
Country
United States
Individual Site Status
Recruiting
Facility Name
Lindner Clinical Trial Center/Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Integris Baptist Office
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220-9442
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Pulmonary Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225-6652
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3011
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5545
Country
United States
Individual Site Status
Recruiting
Facility Name
Allegheny General Hospital of Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Completed
Facility Name
AnMed Health
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor College of Medicine (BCM) - Baylor Heart Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2331
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor Scott White - Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
San Antonio Methodist/TX Transplant Physicians Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3771
Country
United States
Individual Site Status
Recruiting
Facility Name
The Robert Larner, M.D. College of Medicine at The University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College Of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Sanatorio de la Trinidad Mitre
City
Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Guemes
City
C.a.b.a.
ZIP/Postal Code
C1180AAX
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano de Buenos Aires
City
Caba
ZIP/Postal Code
1199ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Ramon Cereijo
City
Caba
ZIP/Postal Code
C1048AAN
Country
Argentina
Individual Site Status
Completed
Facility Name
Centro Médico Dra. De Salvo
City
Caba
ZIP/Postal Code
C1426ABP
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto de Cardiologia de Corrientes
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Medico de La Fundacion Estudios Clinicos
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Cardiovascular de Rosario
City
Rosario
ZIP/Postal Code
S2000DSR
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Flinders Medical Centre
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Prince Charles Hospital
City
Chermside
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Name
St Vincent's hospital
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Hobart Hospital
City
Hobart
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
LKH-Univ. Klinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
The Republican Scientific-Practical Center ''Cardiology''
City
Minsk
ZIP/Postal Code
220036
Country
Belarus
Individual Site Status
Suspended
Facility Name
Minsk Regional Clinical Hospital
City
Minsk
ZIP/Postal Code
220143
Country
Belarus
Individual Site Status
Suspended
Facility Name
ULB Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universidade Federal De Minas Gerais - Hospital das Clínicas
City
Belo Horizonte
ZIP/Postal Code
30130-100
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
City
Belo Horizonte
ZIP/Postal Code
30441-070
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Ceti - Centro de Estudos Em Terapias Inovadoras
City
Curitiba
ZIP/Postal Code
80060-240
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Ynova Pesquisa Clinica
City
Florianopolis
ZIP/Postal Code
88020-210
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Universidade Federal de Goias - Hospital das Clinicas da UFG
City
Goiania
ZIP/Postal Code
74605-020
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Medicina Integral Professor Fernando Figueira
City
Recife
ZIP/Postal Code
50070-902
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao do ABC - Centro Universitario FMABC
City
Santo Andre
ZIP/Postal Code
09060-870
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Secretaria de Estado da Saúde - Instituto Dante Pazzanese de Cardiologia
City
Sao Paulo
ZIP/Postal Code
04012-909
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Das Clinicas Da Faculdade De Medicina Da USP
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
St. Joseph's Health Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Beijing Chaoyang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Anzhen Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South Hospital
City
Changsha
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Name
Renji Hospital
City
Shanghai
ZIP/Postal Code
201112
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongshan Hospital,Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
The General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'An
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Fundacion Neumologica Colombiana
City
Bogota
ZIP/Postal Code
1101131
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Fundacion Cardiovascular de Colombia
City
Bucaramanga - Piedecuesta - Valle De Menzuli
ZIP/Postal Code
6810002
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Clínica Imbanaco S.A.S.
City
Cali
ZIP/Postal Code
760042
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Centro Cardiovascular Colombiano Clínica Santa María
City
Medellin
ZIP/Postal Code
681004
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Hospital Universidad del Norte
City
Soledad
ZIP/Postal Code
0000000
Country
Colombia
Individual Site Status
Recruiting
Facility Name
General University Hospital II.department of Internal Medicine-cardiology and angiology
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B
City
Arhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
CHU de Brest - Hôpital de la Cavale Blanche
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Completed
Facility Name
Hôpital Côte de Nacre
City
Caen Cedex
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud
City
Le Kremlin Bicêtre cedex
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU de Lille - Hopital Claude Huriez
City
Lille Cedex
Country
France
Individual Site Status
Completed
Facility Name
Aphm - Hopital Nord
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Individual Site Status
Completed
Facility Name
Centre Hospitalier Universitaire - de Nice - Hopital Pasteur
City
Nice
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Saint-Etienne - Hôpital Nord
City
St Priest en Jarez Cedex
ZIP/Postal Code
42277
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Larrey CHU de Toulouse
City
Toulouse Cedex 9
Country
France
Individual Site Status
Recruiting
Facility Name
Ruhr-Universität Bochum / Diabeteszentrum
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Individual Site Status
Completed
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMU
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital of Alexandroupolis
City
Alexandroupoli
ZIP/Postal Code
681 00
Country
Greece
Individual Site Status
Recruiting
Facility Name
Alexandra General Hospital of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital Of Larissa
City
Larisa
ZIP/Postal Code
41334
Country
Greece
Individual Site Status
Recruiting
Facility Name
Ahepa University General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem,Pulmonológiai Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Name
NHL Medical College (SVP Hospital IMSR)
City
Ahmedabad
ZIP/Postal Code
380006
Country
India
Individual Site Status
Recruiting
Facility Name
Cims Hospital
City
Ahmedabad
ZIP/Postal Code
381060
Country
India
Individual Site Status
Recruiting
Facility Name
Narayana Hrudayalaya Limited
City
Bangalore
ZIP/Postal Code
560099
Country
India
Individual Site Status
Recruiting
Facility Name
SRM Medical College Hospital & Research Centre
City
Chengalpetu
ZIP/Postal Code
603203
Country
India
Individual Site Status
Recruiting
Facility Name
Govindaswamy Kuppuswamy Naidu Memorial Hospital
City
Coimbatore
ZIP/Postal Code
64103
Country
India
Individual Site Status
Recruiting
Facility Name
HealthWorld Hospitals
City
Durgapur
ZIP/Postal Code
713216
Country
India
Individual Site Status
Recruiting
Facility Name
Care Hospitals
City
Hyderbad
ZIP/Postal Code
500034
Country
India
Individual Site Status
Recruiting
Facility Name
Rabindranath Tagore International Institute of Cardiac Sciences
City
Kolkata
ZIP/Postal Code
700099
Country
India
Individual Site Status
Recruiting
Facility Name
GB Pant Institute of Post Graduate Medical Education & Research
City
New Delhi
ZIP/Postal Code
110002
Country
India
Individual Site Status
Recruiting
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Recruiting
Facility Name
B.D. Mehta Mahavir Heart Institute
City
Surat
ZIP/Postal Code
395001
Country
India
Individual Site Status
Recruiting
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Completed
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Recruiting
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Yitzhak Shamir Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Di Modena, Policlinico Di Modena
City
Modena
ZIP/Postal Code
41125
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Francesco
City
Nuoro
ZIP/Postal Code
08100
Country
Italy
Individual Site Status
Completed
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Toscana Gabriele Monasterio CNR
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Gemelli Universita Cattolica
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
The University of Tokyo Hospital
City
Bunkyo
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kure Kyosai Hospital
City
Hiroshima
ZIP/Postal Code
737-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kagoshima University Hospital
City
Kagoshima City
ZIP/Postal Code
890-8544
Country
Japan
Individual Site Status
Recruiting
Facility Name
St.Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanazawa University Hospital
City
Kanazawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe University Hospital
City
Kobe
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Kurume
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
University Hospital Kyoto Perfectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shinshu University Hospital
City
Matsumoto
ZIP/Postal Code
390-8621
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital
City
Nagoya
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya City University Hospital
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Medical University Hospital
City
Sapporo
ZIP/Postal Code
060-8543
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cerebral and Cardiovascular Center
City
Suita-Shi
ZIP/Postal Code
564-8565
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fujita Health University Hospital
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Tsukuba Hospital
City
Tsukuba-City
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Pulau Pinang
City
George Town
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Serdang
City
Kajang
ZIP/Postal Code
43000
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Sarawak Heart Center
City
Kota Samarahan, Kuching
ZIP/Postal Code
94300
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Institut Jantung Negara (National Heart Institute)
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Cardiologia Dr. Ignacio Chavez
City
Ciudad De México
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez
City
Guadalajara
ZIP/Postal Code
44657
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
City
Mexico
ZIP/Postal Code
52787
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
City
Monterrey
ZIP/Postal Code
64718
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion Clinica Chapultepec
City
Morelia
ZIP/Postal Code
58260
Country
Mexico
Individual Site Status
Recruiting
Facility Name
VUMC Amsterdam
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
St. Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Radboud Umcn
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CN
Country
Netherlands
Individual Site Status
Completed
Facility Name
Akershus Universitetssykehus
City
Nordbyhagen
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Completed
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
372
Country
Norway
Individual Site Status
Completed
Facility Name
Uniwersytecki Szpital Kliniczny w Białymstoku
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Completed
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80214
Country
Poland
Individual Site Status
Recruiting
Facility Name
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalist, Osrodek Badawczo-Rozwojowy
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Individual Site Status
Completed
Facility Name
Centro Hospitalar e Universitário de Coimbra - Hospitais da Universidade de Coimbra
City
Coimbra
ZIP/Postal Code
3004-561
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital De Santa Marta
City
Lisbon
ZIP/Postal Code
1169-024
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Altay Regional Cardiological Dispensary
City
Barnaul
ZIP/Postal Code
656055
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Chelyabinsk Regional Clinical Hospital
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Moscow City Clinical Hospital No.51
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Individual Site Status
Completed
Facility Name
National Medical Research Center of Cardiology of MoH of Russian Federation
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Samara Regional Clinical Cardiological Dispensary
City
Samara
ZIP/Postal Code
443070
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
State Autonomous Healthcare Institution of Tyumen Region 'Scientific and Practical Medical Center'
City
Tumen
ZIP/Postal Code
625032
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Volgograd Regional Clinical Cardiology Center
City
Volgograd
ZIP/Postal Code
400008
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
ZIP/Postal Code
11564
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Name
King Fahad Medical City
City
Riyadh
ZIP/Postal Code
59046
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Institute for Pulmonary Disease of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Individual Site Status
Recruiting
Facility Name
National University Heart Centre, Singapore
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Name
National Heart Centre (NHC) Singapore
City
Singapore
ZIP/Postal Code
169609
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Narodny ustav srdcovych a cievnych chorob
City
Bratislava
ZIP/Postal Code
833 48
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
The Eastern Slovakia Institute of Cardiovascular Diseases
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Milpark Hospital
City
Johannesburg
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Dr Kalla
City
Lenasia
ZIP/Postal Code
1820
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Individual Site Status
Completed
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Pta. de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Costa Del Sol
City
Malaga
ZIP/Postal Code
29603
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sahlgrenska Universitetsjukhuset
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Skanes universitetssjukhus
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Phramongkutklao Hospital and Medical College
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Siriraj Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine
City
Chiang Mai
ZIP/Postal Code
50020
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Srinagarind Hospital, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Songklanagarind hospital
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Adana City Hospital
City
Adana
ZIP/Postal Code
01170
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Cukurova University Medical Faculty
City
Adana
ZIP/Postal Code
01790
Country
Turkey
Individual Site Status
Completed
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Bilkent Sehir Hastanesi
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Akdeniz University Medical Faculty
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Bursa Yuksek Ihtisas Training and Research Hospital
City
Bursa
ZIP/Postal Code
16310
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Pamukkale University Medical Faculty
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Siyami Ersek Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Marmara University Medical Faculty
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Tepecik Training and Research Hospital
City
Izmir
ZIP/Postal Code
35120
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dokuz Eylul University Medical Faculty
City
Izmir
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi
City
Kartal-Istanbul
ZIP/Postal Code
34865
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Mersin University Medical Faculty
City
Mersin
ZIP/Postal Code
33110
Country
Turkey
Individual Site Status
Recruiting
Facility Name
CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
City
Cherkassy
ZIP/Postal Code
18000
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Suspended
Facility Name
MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'
City
Dnipro
ZIP/Postal Code
49070
Country
Ukraine
Individual Site Status
Suspended
Facility Name
CNE' City Clinical Hospital #8' of Kharkiv City Council
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Individual Site Status
Completed
Facility Name
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
02000
Country
Ukraine
Individual Site Status
Suspended
Facility Name
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2RX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Hanoi Medical University Hospital
City
Hanoi
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Cho Ray Hospital
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Tam Anh Hospital
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Tam Duc Heart Hospital
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
University Medical Center Ho Chi Minh city
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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