The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

247

Participants

Timeline

Start Date

May 1, 2016

Primary Completion Date

August 29, 2019

Study Completion Date

April 20, 2020

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

Macitentan

Used open-label in both arms, 10 mg tablet, 1 tablet u.i.d.

DRUG

Tadalafil

Used open-label in both arms, 20 mg tablet, 1-2 tablets u.i.d.

DRUG

Selexipag

Used double-blind in the triple oral treatment arm, 200 microgram tablet, 1-8 tablets b.i.d.

Trial Locations (58)

1070

Hôpital Erasme, Brussels

1090

AKH Wien, Vienna

2010

St. Vincents Hospital Sydney, Darlinghurst

2050

Royal Prince Albert Hospital, Camperdown

2100

Rigshospitalet Copenhagen, Copenhagen

3000

UZ Leuven - Campus Gasthuisberg, Leuven

4020

Krankenhaus der Elisabethinen Linz, Linz

8036

LKH -Universität Klinkum Graz, Graz

8091

Universiätsspital Zürich, Zurich

8200

Aarhus University Hospital Skejby, Aarhus

15212

Allegheny General Hospital of Research, Pittsburgh

15213

UPMC Presbyterian, Pittsburgh

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

21205

Johns Hopkins School of Medicine, Baltimore

28041

Hospital 12 de Octubre, Madrid

30309

Piedmont Pulmonary and Critical Care Research, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

32224

Mayo Clinic Jacksonville, Jacksonville

33331

Cleveland Clinic Florida, Weston

35392

Universitätsklinikum Giessen, Giessen

40138

Ospedale Sant'Orsola, Bologna

40202

Kentuckiana Pulmonary Associates, Louisville

50924

Universitätsklinikum Köln, Cologne

52242

University of Iowa Hospitals & Clinics, Iowa City

60611

Northwestern University, Chicago

63110

Washington University School of Medicine, Saint Louis

69126

Universitätsklinikum Heidelberg, Heidelberg

70112

LSU Health Sciences Center, New Orleans

77030

Houston Methodist Hospital, Houston

85012

Arizona Pulmonary Specialists, LTD, Phoenix

87106

University of New Mexico Hospital, Albuquerque

90095

UCLA Medical Center, Los Angeles

92093

UCSD Health Sciences, La Jolla

93053

Universitätsklinikum Regensburg, Regensburg

94270

CHU de Bicêtre, Le Kremlin-Bicêtre

02111-1552

Tufts Medical Center, Boston

02118-2526

Boston University Medical Center, Boston

45219-2906

The Christ Hospital, Cincinnati

75390-8550

University of Texas Southwestern Medical Center, Dallas

V5Z 1M9

Vancouver General Hospital, Vancouver

N6A 5W9

London Health Sciences Centre - Victoria Hospital, London

M5G 2N2

University of Toronto, Toronto

H3T 1E2

Jewish General Hospital, Montreal

G1V 4G5

Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec

T1Y 6J4

University of Calgary, Calgary

K1Y 4W7

University of Ottawa Heart Institute, Ottawa

01307

Unversitätsklinikum Carl Gustav Carus, Dresden

D07 R2WY

Mater Misericordiae University Hospital, Dublin

1081 HV

VUmc Amsterdam, Amsterdam

6229 HX

Maastricht University Medical Center, Maastricht

08036

Hospital Clinic de Barcelona, Barcelona

221 85

Skånes universitetssjukhus Lund, Lund

901 85

Norrlands universitetssjukhus, Umeå

751 85

Kardiologkliniken, Uppsala

G81 4DY

Golden Jubilee National Hospital, Clydebank

NW3 2QG

The Royal Free Hospital, London

SW3 6NP

Royal Brompton Hospital, London

W12 0HS

Hammersmith Hospital, London

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