在肺动脉高压患者中评估 75 毫克 (mg) 剂量的 Macitentan 的结果研究 (UNISUS)
2026年11月2日 更新者：Actelion
一项 3 期、前瞻性、多中心、双盲、双模拟、随机、主动控制、平行组、组序贯、适应性、事件驱动的研究，以比较 Macitentan 75 mg 与 Macitentan 的疗效、安全性和耐受性10 mg 用于肺动脉高压患者，随后是 75 mg Macitentan 的开放标签治疗期
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.
研究概览
研究类型
介入性
注册 (实际的)
935
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Beijing、中国、100029
- Beijing Anzhen Hospital
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Beijing、中国、100730
- Peking Union Medical College Hospital
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Beijing、中国、100020
- Beijing Chaoyang Hospital
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Changsha、中国、410011
- The Second Xiangya Hospital of Central South Hospital
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Chengdu、中国、610041
- West China Hospital Sichuan University
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Chongqing、中国、400016
- The First Affiliated Hospital of Chongqing Medical University
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Guangzhou、中国、510120
- The First Affiliated Hospital of Guangzhou Medical University
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Shanghai、中国、200433
- Shanghai Pulmonary Hospital
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Shanghai、中国
- Zhongshan Hospital Fudan University
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Shanghai、中国、201112
- Renji Hospital
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Shenyang、中国、110000
- The General Hospital of Northern Theater Command
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Shenyang、中国、110004
- Shengjing Hospital Of China Medical University
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Tianjin、中国、300052
- Tianjin Medical University General Hospital
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Xi'an、中国、710061
- The First Affiliated Hospital of Xian Jiaotong University
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Aarhus、丹麦、8200
- Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B
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Cherkassy、乌克兰、18000
- CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
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Cherkasy、乌克兰、18009
- Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
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Dnipro、乌克兰、49070
- MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'
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Kharkiv、乌克兰、61176
- CNE' City Clinical Hospital #8' of Kharkiv City Council
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Kyiv、乌克兰、03680
- State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
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Kyiv、乌克兰、02000
- SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
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Lviv、乌克兰、79010
- Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
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Ternopil、乌克兰、46002
- Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
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Haifa、以色列、34362
- Carmel Medical Center
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Jerusalem、以色列、91031
- Shaare Zedek Medical Center
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Rehovot、以色列、76100
- Kaplan Medical Center
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Tel HaShomer、以色列、5265601
- The Chaim Sheba Medical Center
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Tsrifin、以色列、70300
- Yitzhak Shamir Medical Center
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Barnaul、俄罗斯、656055
- Altay Regional Cardiological Dispensary
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Chelyabinsk、俄罗斯、454076
- Chelyabinsk Regional Clinical Hospital
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Kazan'、俄罗斯、420101
- State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'
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Kemerovo、俄罗斯、650002
- Scientific and Research Institution of Cardiovascular Diseases Complex Problems
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Moscow、俄罗斯、121309
- Moscow City Clinical Hospital No.51
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Moscow、俄罗斯、121552
- National Medical Research Center of Cardiology of MoH of Russian Federation
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Saint Petersburg、俄罗斯、197341
- National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation
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Samara、俄罗斯、443070
- Samara Regional Clinical Cardiological Dispensary
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Tyumen、俄罗斯、625032
- State Autonomous Healthcare Institution of Tyumen Region 'Scientific and Practical Medical Center'
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Volgograd、俄罗斯、400008
- Volgograd Regional Clinical Cardiology Center
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Sofia、保加利亚、1309
- Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead
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Sofia、保加利亚、1750
- University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
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Ontario
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Hamilton、Ontario、加拿大、L8N 4A6
- St. Joseph's Health Centre
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Ottawa、Ontario、加拿大、K1Y 4W7
- University of Ottawa Heart Institute
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Toronto、Ontario、加拿大、M5G2C4
- University Health Network - Toronto General Hospital
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Quebec
-
Montreal、Quebec、加拿大、H3T 1E2
- Jewish General Hospital
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-
-
-
-
Budapest、匈牙利、1083
- Semmelweis Egyetem,Pulmonológiai Klinika
-
Budapest、匈牙利、1096
- Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet Felnott kardiologiai osztaly
-
Pécs、匈牙利、7624
- Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
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Szeged、匈牙利、6720
- Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő
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Johannesburg、南非
- Milpark Hospital
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Lenasia、南非、1820
- Dr Kalla
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-
-
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Ahmedabad、印度、380006
- NHL Medical College (SVP Hospital IMSR)
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Ahmedabad、印度、381060
- Cims Hospital
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Bangalore、印度、560099
- Narayana Hrudayalaya Limited
-
Chengalpetu、印度、603203
- SRM Medical College Hospital & Research Centre
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Coimbatore、印度、64103
- Govindaswamy Kuppuswamy Naidu Memorial Hospital
-
Durgapur、印度、713216
- HealthWorld Hospitals
-
Hyderabad、印度、500034
- Renova Century Hospitals
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Hyderbad、印度、500034
- Care Hospitals
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Kolkata、印度、700099
- Rabindranath Tagore International Institute of Cardiac Sciences
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New Delhi、印度、110060
- Sir Ganga Ram Hospital
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New Delhi、印度、110002
- GB Pant Institute of Post Graduate Medical Education & Research
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Puducherry、印度、605008
- Jawaharlal Institute of Postgraduate Medical Education and Research
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Surat、印度、395001
- B.D. Mehta Mahavir Heart Institute
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-
-
-
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Tainan、台湾、704
- National Cheng Kung University Hospital
-
Taipei、台湾、10002
- National Taiwan University Hospital
-
Taipei、台湾、10449
- Mackay Memorial Hospital
-
Taipei、台湾、112
- Taipei Veterans General Hospital
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-
-
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Bogotá、哥伦比亚、1101131
- Fundacion Neumologica Colombiana
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Bucaramanga - Piedecuesta - Valle de Menzuli、哥伦比亚、6810002
- Fundacion Cardiovascular de Colombia
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Cali、哥伦比亚、760042
- Clínica Imbanaco S.A.S.
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Medellín、哥伦比亚、681004
- Centro Cardiovascular Colombiano Clínica Santa María
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Soledad、哥伦比亚、0000000
- Hospital Universidad del Norte
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-
-
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Adana、土耳其（türkiye）、01170
- Adana City Hospital
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Adana、土耳其（türkiye）、01790
- Cukurova University Medical Faculty
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Ankara、土耳其（türkiye）、06500
- Gazi University Medical Faculty
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Ankara、土耳其（türkiye）、06800
- Ankara Bilkent Sehir Hastanesi
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Ankara、土耳其（türkiye）、06230
- Hacettepe University Medical Faculty
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Ankara、土耳其（türkiye）、06170
- Ankara Etlik Speciality Hospital
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Antalya、土耳其（türkiye）、07059
- Akdeniz University Medical Faculty
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Bursa、土耳其（türkiye）、16310
- Bursa Yuksek Ihtisas Training and Research Hospital
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Denizli、土耳其（türkiye）、20160
- Pamukkale Universitesi Tip Fakultesi Hastanesi
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Istanbul、土耳其（türkiye）、34899
- Marmara University Medical Faculty
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Istanbul、土耳其（türkiye）、34668
- Siyami Ersek Training and Research Hospital
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Izmir、土耳其（türkiye）、35100
- Ege Universitesi Tip Fakultesi Hastanesi
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Izmir、土耳其（türkiye）、35020
- SBU Izmir Tepecik Egitim Ve Arastirma Hastanesi
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Izmir、土耳其（türkiye）、35330
- Dokuz Eylul Universitesi Tip Fakültesi Hastanesi
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Kartal Istanbul、土耳其（türkiye）、34865
- Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi
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Mersin、土耳其（türkiye）、33110
- Mersin University Medical Faculty
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Belgrade、塞尔维亚、11000
- University Clinical Center of Serbia
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Kamenitz、塞尔维亚、21204
- Institute for Pulmonary Disease of Vojvodina
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Guadalajara、墨西哥、44657
- Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez
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Mexico City、墨西哥、14080
- Instituto Nacional de Cardiologia Dr. Ignacio Chavez
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Monterrey、墨西哥、64460
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Monterrey、墨西哥、64718
- Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
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Morelia、墨西哥、58260
- Centro de Investigacion Clinica Chapultepec
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México、墨西哥、52787
- Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
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Graz、奥地利、8036
- LKH-Univ. Klinikum Graz
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Linz、奥地利、4020
- Ordensklinikum Linz GmbH Elisabethinen
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Vienna、奥地利、1090
- Medical University Vienna
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-
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Belo Horizonte、巴西、30441-070
- Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
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Belo Horizonte、巴西、30130-100
- Universidade Federal De Minas Gerais - Hospital das Clínicas
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Brasília、巴西、70840-901
- Empresa Brasileira de Servicos Hospitalares-EBSERH-Hospital Universitario de Brasilia
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Campina Grande do Sul、巴西、83430-000
- Sociedade Hospitalar Angelina Caron - Hospital Angelina Caron
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Curitiba、巴西、80060-240
- Ceti - Centro de Estudos Em Terapias Inovadoras
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Florianópolis、巴西、88020 210
- Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
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Goiânia、巴西、74605 020
- Hospital das Clinicas - UFG
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Porto Alegre、巴西、90610-000
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Porto Alegre、巴西、90035 903
- Hospital De Clinicas De Porto Alegre
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Recife、巴西、50070-902
- Instituto de Medicina Integral Professor Fernando Figueira
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São Paulo、巴西、05403-000
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
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São Paulo、巴西、04012-909
- Instituto Dante Pazzanese de Cardiologia
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São Paulo、巴西、09060-870
- Cepes - Fmabc
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Alexandroupoli、希腊、681 00
- University Hospital of Alexandroupolis
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Athens、希腊、11528
- Alexandra General Hospital of Athens
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Larissa、希腊、41334
- University Hospital Of Larissa
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Thessaloniki、希腊、54636
- Ahepa University General Hospital of Thessaloniki
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Bad Oeynhausen、德国、32545
- Ruhr Universitat Bochum Diabeteszentrum
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Hanover、德国、30625
- Medizinische Hochschule Hannover
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München、德国、81377
- Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMU
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Regensburg、德国、93053
- Universitaetsklinikum Regensburg
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Milan、意大利、20162
- ASST Grande Ospedale Metropolitano Niguarda
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Modena、意大利、41125
- AOU Di Modena Policlinico Di Modena
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Nuoro、意大利、08100
- Ospedale San Francesco
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Pavia、意大利、27100
- Fondazione IRCCS Policlinico San Matteo
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Pisa、意大利、56124
- Fondazione Toscana Gabriele Monasterio CNR
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Roma、意大利、00168
- Policlinico Gemelli Universita Cattolica
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Nordbyhagen、挪威、1478
- Akershus Universitetssykehus
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Oslo、挪威、372
- Oslo University Hospital
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Prague、捷克语、128 08
- General University Hospital II.department of Internal Medicine-cardiology and angiology
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Bratislava、斯洛伐克、833 48
- Narodny ustav srdcovych a cievnych chorob
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Košice、斯洛伐克、040 11
- The Eastern Slovakia Institute of Cardiovascular Diseases
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-
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Singapore、新加坡、119228
- National University Heart Centre, Singapore
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Singapore、新加坡、169609
- National Heart Centre (NHC) Singapore
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-
-
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Bunkyō City、日本、113-8655
- The University of Tokyo Hospital
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Fukuoka、日本、812 8582
- Kyushu University Hospital
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Hiroshima、日本、737-8505
- Kure Kyosai Hospital
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Kagoshima、日本、890 8520
- Kagoshima University Hospital
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Kanagawa、日本、216 8511
- St Marianna University Hospital
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Kanazawa、日本、920 8641
- Kanazawa University Hospital
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Kobe、日本、650 0017
- Kobe University Hospital
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Kurume、日本、830-0011
- Kurume University Hospital
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Kyoto、日本、602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Kyoto、日本、606 8507
- Kyoto University Hospital
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Matsumoto、日本、390 8621
- Shinshu University Hospital
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Nagasaki、日本、852-8501
- Nagasaki University Hospital
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Nagoya、日本、467 8602
- Nagoya City University Hospital
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Nagoya、日本、466 8560
- Nagoya University Hospital
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Niigata、日本、951 8520
- Niigata University Medical And Dental Hospital
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Okayama、日本、701-1192
- National Hospital Organization Okayama Medical Center
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Okayama、日本、700 8558
- Okayama University Hospital
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Sapporo、日本、060-8648
- Hokkaido University Hospital
-
Sapporo、日本、060 8543
- Sapporo Medical University Hospital
-
Suita-Shi、日本、564-8565
- National Cerebral and Cardiovascular Center
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Tokyo、日本、113-8431
- Juntendo University Hospital
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Toyoake、日本、470-1192
- Fujita Health University Hospital
-
Tsukuba、日本、305 8576
- University of Tsukuba Hospital
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-
-
-
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Brussels、比利时、1070
- ULB Hôpital Erasme
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Leuven、比利时、3000
- UZ Leuven
-
-
-
-
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Riyadh、沙特阿拉伯、59046
- King Fahad Medical City
-
Riyadh、沙特阿拉伯、11564
- King Faisal Specialist Hospital & Research Center
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-
-
-
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Brest、法国、29200
- CHU de Brest - Hopital de la Cavale Blanche
-
Caen、法国
- Hôpital Côte de Nacre
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Le Kremlin-Bicêtre、法国、94270
- Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
-
Lille、法国
- CHRU de Lille Hopital Claude Huriez
-
Marseille、法国、13915
- Aphm - Hopital Nord
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Nice、法国、06002
- Centre Hospitalier Universitaire - de Nice - Hopital Pasteur
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Saint-Priest-en-Jarez、法国、42277
- CHU Saint Etienne Hopital Nord
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Toulouse、法国
- Hopital Larrey CHU de Toulouse
-
-
-
-
-
Bialystok、波兰、15 276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
Bydgoszcz、波兰、85-168
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
-
Gdansk、波兰、80214
- Uniwersyteckie Centrum Kliniczne
-
Katowice、波兰、40 635
- SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
-
Krakow、波兰、31 202
- Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
-
Szczecin、波兰、70 111
- Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie
-
Warsaw、波兰、02 507
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
-
Wroclaw、波兰、51 124
- Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo Rozwojowy
-
-
-
-
-
Bangkok、泰国、10700
- Siriraj Hospital Mahidol University
-
Bangkok、泰国、10400
- Phramongkutklao Hospital and Medical College
-
Bangkok、泰国、10400
- Ramathibodi Hospital Mahidol University
-
Chiang Mai、泰国、50020
- Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
-
Khon Kaen、泰国、40002
- Srinagarind Hospital, Khon Kaen University
-
Songkhla、泰国、90110
- Songklanagarind hospital
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-
-
-
-
Bedford Park、澳大利亚、5042
- Flinders Medical Centre
-
Camperdown、澳大利亚、2050
- Royal Prince Alfred Hospital
-
Chermside、澳大利亚、4032
- The Prince Charles Hospital
-
Darlinghurst、澳大利亚、2010
- St Vincent's hospital
-
Hobart、澳大利亚、7000
- Royal Hobart Hospital
-
Murdoch、澳大利亚、6150
- Fiona Stanley Hospital
-
Westmead、澳大利亚、2145
- Westmead Hospital
-
-
-
-
-
Gothenburg、瑞典、413 45
- Sahlgrenska Universitetsjukhuset
-
Lund、瑞典、221 85
- Skanes universitetssjukhus
-
-
-
-
-
Minsk、白俄罗斯、220036
- The Republican Scientific-Practical Center ''Cardiology''
-
Minsk、白俄罗斯、220143
- Minsk Regional Clinical Hospital
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-
-
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Arizona
-
Phoenix、Arizona、美国、85054
- Mayo Clinic
-
Scottsdale、Arizona、美国、85258
- Arizona Pulmonary Specialists, Ltd
-
-
California
-
La Jolla、California、美国、92037
- Scripps Memorial Hospital
-
Los Angeles、California、美国、90033
- USC Keck
-
Santa Barbara、California、美国、93105
- Jeffrey S. Sager, MD Medical Corporation
-
Torrance、California、美国、90502-2006
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
-
-
Colorado
-
Denver、Colorado、美国、80206
- National Jewish Health
-
-
Florida
-
Weston、Florida、美国、33331 3609
- Cleveland Clinic
-
-
Georgia
-
Atlanta、Georgia、美国、30309
- Piedmont Healthcare
-
Atlanta、Georgia、美国、30342
- Northside Hospital
-
-
Illinois
-
Oak Lawn、Illinois、美国、60453
- Advocate Christ Medical Center
-
-
Indiana
-
Indianapolis、Indiana、美国、46202
- Indiana University
-
Indianapolis、Indiana、美国、46260
- St. Vincent Medical Group, Inc.
-
-
Iowa
-
Iowa City、Iowa、美国、52242
- University Of Iowa - Hospitals & Clinics
-
-
Kentucky
-
Louisville、Kentucky、美国、40202
- Norton Pulmonary Specialists
-
-
Louisiana
-
New Orleans、Louisiana、美国、70112 7021
- Louisiana State University
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109-5000
- University of Michigan
-
Troy、Michigan、美国、53215
- Troy Beaumont
-
-
Missouri
-
St Louis、Missouri、美国、63110
- Saint Louis University Academic Pavillion
-
St Louis、Missouri、美国、63110-1032
- Washington University School Of Medicine
-
-
Nebraska
-
Omaha、Nebraska、美国、68198-2265
- University of Nebraska Medical Center
-
-
Nevada
-
Reno、Nevada、美国、89511
- Reno Heart Institute
-
-
New York
-
Mineola、New York、美国、11501
- Winthrop University Hospital
-
New York、New York、美国、10032
- Columbia University
-
New York、New York、美国、10029
- Mount Sinai
-
Stony Brook、New York、美国、11794
- Stony Brook University Medical Center
-
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North Carolina
-
Durham、North Carolina、美国、27710-4000
- Duke
-
-
Ohio
-
Cincinnati、Ohio、美国、45219
- Lindner Clinical Trial Center/Christ Hospital
-
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Oklahoma
-
Oklahoma City、Oklahoma、美国、73112
- Integris Baptist Office
-
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Oregon
-
Beaverton、Oregon、美国、97008
- The Oregon Clinic Pulmonary West
-
Portland、Oregon、美国、97220-9442
- The Oregon Clinic
-
Portland、Oregon、美国、97239-3011
- Oregon Health And Science University
-
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Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104-5545
- University of Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15212
- Allegheny General Hospital of Research
-
Wynnewood、Pennsylvania、美国、19096
- Lankenau Medical Center
-
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South Carolina
-
Anderson、South Carolina、美国、29621
- AnMed Health
-
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Texas
-
Dallas、Texas、美国、75390
- UT Southwestern Medical Center
-
Houston、Texas、美国、77030
- Baylor College of Medicine (BCM) - Baylor Heart Clinic
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Plano、Texas、美国、75093
- Baylor Scott White - Plano
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San Antonio、Texas、美国、78229-3771
- San Antonio Methodist TX Transplant Physicians Group
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Vermont
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Burlington、Vermont、美国、05405
- The Robert Larner, M.D. College of Medicine at The University of Vermont
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Wisconsin
-
Madison、Wisconsin、美国、53792
- University of Wisconsin Hospital and Clinics
-
Milwaukee、Wisconsin、美国、53226
- Medical College Of Wisconsin
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-
-
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London、英国、NW3 2QG
- Royal Free Hospital
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Newcastle upon Tyne、英国、NE7 7DN
- Freeman Hospital
-
Sheffield、英国、S10 2RX
- Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
-
-
-
-
-
Amsterdam、荷兰、1081 HV
- VUMC Amsterdam
-
Nieuwegein、荷兰、3435 CM
- St. Antonius Ziekenhuis Nieuwegein
-
Nijmegen、荷兰、6525 GA
- Radboud Umcn
-
Rotterdam、荷兰、3015 CN
- Erasmus MC
-
-
-
-
-
Coimbra、葡萄牙、3004 561
- Uls Coimbra - Hosp. Univ. Coimbra
-
Lisbon、葡萄牙、1169-024
- Uls Sao Jose - Hosp. Santa Marta
-
Lisbon、葡萄牙、1769-001
- Uls Santa Maria - Hosp. Pulido Valente
-
-
-
-
-
Barcelona、西班牙、8003
- Hosp. Del Mar
-
Barcelona、西班牙、08035
- Hosp Univ Vall D Hebron
-
Madrid、西班牙、28041
- Hosp. Univ. 12 de Octubre
-
Madrid、西班牙、28046
- Hosp. Univ. La Paz
-
Madrid、西班牙、28222
- Hosp. Univ. Pta. de Hierro Majadahonda
-
Málaga、西班牙、29603
- Hosp. Costa Del Sol
-
Salamanca、西班牙、37007
- Hosp Clinico Univ de Salamanca
-
-
-
-
-
Hanoi、越南
- Hanoi Medical University Hospital
-
Ho Chi Minh City、越南、700000
- Cho Ray Hospital
-
Ho Chi Minh City、越南、700000
- Tam Anh Hospital
-
Ho Chi Minh City、越南、700000
- Tam Duc Heart Hospital
-
Ho Chi Minh City、越南、700000
- University Medical Center Ho Chi Minh city
-
-
-
-
-
Buenos Aires、阿根廷、C1039AAO
- Sanatorio de la Trinidad Mitre
-
C.a.b.a.、阿根廷、C1180AAX
- Sanatorio Guemes
-
Caba、阿根廷、C1426ABP
- Centro Médico Dra. De Salvo
-
Caba、阿根廷、1199ABB
- Hospital Italiano de Buenos Aires
-
Caba、阿根廷、C1048AAN
- Sanatorio Ramon Cereijo
-
Corrientes、阿根廷、W3400AMZ
- Instituto de Cardiologia de Corrientes
-
Rosario、阿根廷、S2000DSR
- Instituto Cardiovascular de Rosario
-
Rosario、阿根廷、2000
- Instituto Medico de La Fundacion Estudios Clinicos
-
-
-
-
-
Seoul、韩国、05505
- Asan Medical Center
-
Seoul、韩国、03722
- Severance Hospital Yonsei University Health System
-
Seoul、韩国、06351
- Samsung Medical Center
-
Seoul、韩国、3080
- Seoul National University Hospital
-
-
-
-
-
George Town、马来西亚、10990
- Hospital Pulau Pinang
-
Kajang、马来西亚、43000
- Hospital Serdang
-
Kota Samarahan、马来西亚、94300
- Sarawak Heart Center
-
Kuala Lumpur、马来西亚、50400
- Institut Jantung Negara (National Heart Institute)
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Macitentan 10 milligrams (mg) + Placebo
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. |
Participants will receive macitentan 10 mg film-coated tablets orally.
其他名称：
Participants will receive macitentan 37.5 mg film-coated tablets orally.
其他名称：
Participants will receive macitentan 75 mg film-coated tablets orally.
其他名称：
Participants will receive matching placebo film-coated tablets orally. |
|
实验性的：Macitentan 75 mg + Placebo
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. |
Participants will receive macitentan 10 mg film-coated tablets orally.
其他名称：
Participants will receive macitentan 37.5 mg film-coated tablets orally.
其他名称：
Participants will receive macitentan 75 mg film-coated tablets orally.
其他名称：
Participants will receive matching placebo film-coated tablets orally. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) Events
大体时间：Up to 4 years
|
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. |
Up to 4 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Double-blind Treatment Period: Change From Baseline to Week 24 in 6MWD
大体时间：Baseline up to Week 24
|
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. |
Baseline up to Week 24
|
|
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
大体时间：Up to 4 years
|
Number of Participants with CEC-adjudicated death or hospitalization due to PAH will be reported. |
Up to 4 years
|
|
Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiopulmonary Symptom Domain Score
大体时间：Baseline up to Week 24
|
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. |
Baseline up to Week 24
|
|
Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiovascular Symptom Domain Score
大体时间：Baseline up to Week 24
|
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. |
Baseline up to Week 24
|
|
Double-blind Treatment Period: Time to Death Occurring Between Randomization and End of Double-blind Treatment (EDBT)
大体时间：Up to 4 years
|
Time to death occurring between randomization and EDBT will be reported. |
Up to 4 years
|
|
Treatment Extension Period: Time to Death Occurring Between Randomization and End of Study (EOS)
大体时间：Up to 6 years
|
Time to death occurring between randomization and EOS will be reported. |
Up to 6 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任：Actelion Clinical Trials、Actelion
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年6月30日
初级完成 (实际的)
2025年10月7日
研究完成 (估计的)
2029年2月20日
研究注册日期
首次提交
2020年1月31日
首先提交符合 QC 标准的
2020年2月14日
首次发布 (实际的)
2020年2月18日
研究记录更新
最后更新发布 (实际的)
2026年11月3日
上次提交的符合 QC 标准的更新
2026年11月2日
最后验证
2026年11月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CR108740
- 2019-002533-11 (EudraCT编号)
- AC-055-315 (其他标识符：Janssen Research & Development, LLC)
- 2024-515669-32-00 (注册表标识符：EUCT number)
- 2019 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.