Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

PHASE3CompletedINTERVENTIONAL
Enrollment

187

Participants

Timeline

Start Date

July 29, 2019

Primary Completion Date

August 23, 2022

Study Completion Date

September 27, 2024

Conditions
Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
Interventions
DRUG

FDC macitentan/tadalafil

Film-coated tablet with 10 mg macitentan and 40 mg tadalafil, to be administered orally once daily.

DRUG

Macitentan 10 mg

Film-coated tablet with 10 mg macitentan, to be administered orally once daily.

DRUG

Tadalafil 40 mg

Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily.

DRUG

Placebo FDC

Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.

DRUG

Placebo macitentan

Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.

DRUG

Placebo tadalafil

Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.

Trial Locations (148)

112

Taipei Veterans General Hospital, Taipei

333

Chang-Gung Memorial Hospital, LinKou Branch, Taoyuan District

704

National Cheng Kung University Hospital, Tainan City

813

Kaohsiung Veterans General Hospital, Kaohsiung City

1083

Semmelweis Egyetem,Pulmonológiai Klinika, Budapest

1096

Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály, Budapest

1309

National Heart Hospital, Sofia

1750

University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD, Sofia

1820

Dr Kalla, Lenasia

4001

Abdullah, IA, Durban

4064

Core Research Group, Milton

5000

Royal Adelaide Hospital, Adelaide

6100

Hacettepe University Medical Faculty, Ankara

6500

Ankara University Medical Faculty, Ankara

6725

Szegedi Tudomanyegyetem, Szeged

7000

Pulmonary Arterial Hypertension Clinic, Hobart

7624

Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs

8035

Hosp Univ Vall D Hebron, Barcelona

10002

National Taiwan University Hospital, Taipei

10449

Mackay Memorial Hospital, Taipei

14080

Instituto Nacional de Cardiologia Dr. Ignacio Chavez, México

15213

University of Pittsburgh Medical Center, Pittsburgh

16310

Bursa Yuksek Ihtisas Training and Research Hospital, Bursa

17475

Universitat Greifswald, Greifswald

19107

Thomas Jefferson University Hospital, Philadelphia

20090

Azienda Ospedaliera San Gerardo, Monza

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

20246

Universitaetsklinikum Hamburg Eppendorf, Hamburg

25123

Cardiologia c/o Spedali Civili, Brescia

26506

WVU Health Sciences Center, Morgantown

26871

Kardiologische Praxis Papenburg, Papenburg

27100

IRCCS Policlinico San Matteo, Università degli studi di Pavi, Pavia

27514

The University of North Carolina at Chapel Hill, Chapel Hill

27835

Pitt County Memorial Hospital d/b/a Vidant Medical Center, Greenville

28034

Hosp. Univ. Ramon Y Cajal, Madrid

28040

Hosp Univ Fund Jimenez Diaz, Madrid

28046

Hosp. Univ. La Paz, Madrid

30060

WellStar Health System, Marietta

30309

Piedmont Healthcare, Atlanta

33110

Mersin University Medical Faculty, Mersin

34096

Istanbul University - Cerrahpasa Cardiology Institution, Istanbul

Istanbul University Cerrahpasa Medical Faculty, Istanbul

34865

Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi, Kartal Istanbul

34899

Marmara University Medical Faculty, Istanbul

35100

Ege University School of Medicine, Izmir

35340

Dokuz Eylul University Hospital, Izmir

35392

Universitaetsklinikum Giessen, Giessen

37007

Hosp Clinico Univ de Salamanca, Salamanca

39011

Hosp. Univ. Marques de Valdecilla, Santander

42131

Konya Selcuk University Medical Faculty, Konya

44503

St. Elizabeth Hospital Mercy Bon Secors, Youngstown

45004

Hosp. Virgen de La Salud, Toledo

45267

University of Cincinnati, Cincinnati

46014

Hosp. Gral. Univ. Valencia, Valencia

48912

Sparrow Clinical Research Institute, Lansing

50400

Institut Jantung Negara (National Heart Institute), Kuala Lumpur

52242

University of Iowa Hospitals and Clinics, Iowa City

53105

Universitatsklinikum Bonn, Bonn

53226

Medical College of Wisconsin Froedtert Hospital, Milwaukee

53792

University of Wisconsin At Madison, Madison

55407

Minneapolis Heart Institute Foundation, Minneapolis

57105

Sanford Health, Sioux Falls

58122

Sanford Health, Fargo

61614

OSF HealthCare Cardiovascular Institute, Peoria

63110

Washington University School Of Medicine, St Louis

64718

Unidad de Investigacion Clinica en Medicina S.C. (UDICEM), Monterrey

69126

Thoraxklinik am Universitatsklinikum Heidelberg, Heidelberg

70124

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari, Bari

75093

Baylor Scott White - Plano, Plano

75390

University of Texas Southwestern Medical Center, Dallas

89509

VA Sierra Nevada Health Care System, Reno

90033

University of Southern California, Los Angeles

92835

Providence Medical Foundation, Fullerton

93053

Universitaetsklinikum Regensburg, Regensburg

94300

Sarawak Heart Center, Kuching

97074

Klinikum Würzburg Mitte gGmbH Standort Missioklinik, Würzburg

97210

Legacy Hospital, Portland

97239

Oregon Health and Science University, Portland

100029

Beijing Anzhen Hospital, Beijing

110000

The General Hospital of Northern Theater Command, Shenyang

121552

National Medical Research Center of Cardiology of MoH of Russian Federation, Moscow

129090

GU Moscow Regional Research Clinical Institute n.a. M.F.Vla, Moscva

197341

National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation, Saint Petersburg

200433

Shanghai Pulmonary Hospital, Shanghai

300052

Tianjin Medical University General Hospital, Tianjin

410011

The Second Xiangya Hospital of Central South Hospital, Changsha

443070

Samara Regional Clinical Cardiological Dispensary, Samara

510120

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

650002

Scientific and Research Institution of Cardiovascular Diseases Complex Problems, Kemerovo

656055

Altay Regional Cardiological Dispensary, Barnaul

710061

The First Affiliated Hospital of Xian Jiaotong University, Xi'an

40202-1332

Norton Healthcare, Louisville

30130-100

Universidade Federal De Minas Gerais - Hospital das Clínicas, Belo Horizonte

30441-070

Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa, Belo Horizonte

18618-686

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu), Botucatu

60840-285

Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes, Fortaleza

74605-020

Universidade Federal de Goias - Hospital das Clinicas da UFG, Goiânia

90035-007

Hospital das Clinicas de Porto Alegre, Porto Alegre

90035-074

Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS, Porto Alegre

04024-002

SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo, São Paulo

05403-000

Hospital Das Clinicas Da Faculdade De Medicina Da USP, São Paulo

T1Y 6J4

Alberta Health Services, Calgary

T6G 2G3

University of Alberta, Edmonton

V5Z 1M9

Vancouver General Hospital, Vancouver

N6A 5W9

London Health Sciences Centre, London

Unknown

Jiangsu Province Hospital, Nanjing

128 08

General University Hospital II.department of Internal Medicine-cardiology and angiology, Prague

01307

Universitatsklinikum Carl Gustav Carus Dresden, Dresden

08100

Ospedale San Francesco, Nuoro

00161

Policlinico Umberto I, Roma

113-8655

The University of Tokyo Hospital, Bunkyō City

260 8677

Chiba University Hospital, Chiba

812 8582

Kyushu University Hospital, Fukuoka

960 1295

Fukushima Medical University Hospital, Fukushima

371-0034

Gunma University Hospital, Gunma

737-8505

Kure Kyosai Hospital, Hiroshima

259-1193

Tokai University Hospital, Isehara

890-8544

Kagoshima University Hospital, Kagoshima

920 8641

Kanazawa University Hospital, Kanazawa

650 0017

Kobe University Hospital, Kobe

860-8556

Kumamoto University Hospital, Kumamoto

830-0011

Kurume University Hospital, Kurume

602-8566

University Hospital Kyoto Prefectural University of Medicine, Kyoto

606 8507

Kyoto University Hospital, Kyoto

390 8621

Shinshu University Hospital, Matsumoto

181-8611

Kyorin University Hospital, Mitaka

852-8501

Nagasaki University Hospital, Nagasaki

700 8558

Okayama University Hospital, Okayama

701-1192

National Hospital Organization Okayama Medical Center, Okayama

060-8543

Sapporo Medical University Hospital, Sapporo

060-8648

Hokkaido University Hospital, Sapporo

980 8574

Tohoku University Hospital, Sendai

564-8565

National Cerebral and Cardiovascular Center, Suita-Shi

113-8431

Juntendo University Hospital, Tokyo

514 8507

Mie University Hospital, Tsu

305 8576

University of Tsukuba Hospital, Tsukuba

15 276

Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku, Bialystok

85-168

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii, Bydgoszcz

80 214

Uniwersyteckie Centrum Kliniczne, Gdansk

40 635

GCM SUM I Oddzial Kardiologii, Katowice

91 347

Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego, Lodz

20-718

Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ, Oddzial Kardiologii, Lublin

05-400

ECZ Otwock Klinika Kardiologii Klinika Krazenia Plucnego Chorob Zakrzepowo Zatorowych i Kardiologii, Otwock

70 111

Uniwersytecki Szpital Kliniczny nr 2 PUM Klinika Kardiologii, Szczecin

51 124

Wojewodzki Szpital Specjalistyczny Oddzial Kardiologiczny, Wroclaw

08036

Hosp Clinic de Barcelona, Barcelona

01790

Cukurova University Medical Faculty, Adana

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY

NCT03904693 - Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Biotech Hunter | Biotech Hunter