PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial

PHASE4CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

June 23, 2015

Primary Completion Date

October 25, 2017

Study Completion Date

October 31, 2018

Conditions
Portopulmonary Hypertension
Interventions
DRUG

Macitentan

Macitentan film-coated tablet 10 mg once daily.

OTHER

Placebo

Matching placebo tablet once daily.

Trial Locations (52)

14033

CHU Côte de Nacre, Service de Pneumologie, Caen

15213

UPMC Montefiore, Pittsburgh

19104

University of Pennsylvania, Philadelphia

28041

Hospital Universitario12 Octubre, Madrid

29609

CHRU Hôpital Cavale Blanche Brest, Brest

30106

Piedmont Healthcare, Austell

30322

Emory Healthcare, Atlanta

30625

Medizinische Hochschule Hannover, Abteilung Pneumologie, Hanover

31059

CHU Toulouse - Hôpital Larrey Hôpital de Jour et Semaine, Toulouse

32209

University of Florida College of Medicine, Jacksonville

32224

Mayo Clinic Florida - Pulmonary Dept., Jacksonville

32610

University of Florida - Divison of Pulmonary Critical Care & Sleep, Gainesville

33136

University of Miami, Miami

33143

South Miami Hospital, South Miami

35033

"Hôpital Pontchaillou - CHU Rennes Service de Cardiologie et des Maladies Vasculaires Rennes Cedex 9 35033", Rennes

35392

Universitätsklinikum Giessen und Marburg GmbH Justus-Liebig Universität Giessen 35392, Giessen

38043

CHRU de Grenoble, Hôpital Albert Michallon, Grenoble

40202

Kentuckiana Pulmonary Associates, Louisville

44195

Cleveland Clinic - Department of Cardiovascular Medicine, Cleveland

45267

University of Cincinnati, Cincinnati

46202

Indiana University, Indianapolis

48202

Henry Ford Hospital, Detroit

55905

Mayo Clinic, Rochester

59037

"Hôpital cardiologique, Service de cardiologie 59037 Lille Cedex", Lille

60611

Northwestern University, Chicago

69126

Thoraxklinik des Universitätsklinikums Heidelberg Zentrum für pulmonale Hypertonie Studienkoordination, Heidelberg

69677

"Hôpital Cardiologique et Pneumologique Louis Pradel 69677 Bron cedex", Lyon

75226

Baylor University Medical Center, Dallas

76031

CHU Rouen, Rouen

77030

Methodist Hospital, Houston

78229

Methodist Hospital, San Antonio

80045

University of Colorado Health Sciences Center Aurora, Aurora

85054

Mayo Clinic -Clinical Studies Unit, Phoenix

90033

Keck School of Medicine, Los Angeles

92093

UCSD, La Jolla

94275

Hôpital Kremlin Bicêtre Service de Pneumologie, Paris

90025-1690

David Geffen School of Medicine, UCLA, Los Angeles

91413-2204

UCSF, San Francisco

02118

Boston University, Boston

87131-0001

University of New Mexico Health Science Center, Albuquerque

75390-8550

University of Texas Southwestern Medical Center Division of NeuroCritical Care 75390-8550, Dallas

53705-2281

University of Wisconsin-Madison, Madison

92020-090

Servico de Hipertensao Pulmonar - Complexo Hospitalar Santa Casa Irmandade Santa de Misericordia de Porto Alegre, Porto Alegre

05403-000

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP), São Paulo

128 08

Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie U, Prague

140 21

IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine), Prague

01307

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden

04103

Universitätsklinikum Leipzig, Department Innere Medizin, Abteilung Pneumologie, Leipzig

08036

Hospital Clinico i Provincial Servicio de Neumología, Barcelona

G11 6NT

NHS Greater Glasgow and Clyde Trust, Glasgow

NW3 2QG

The Royal Free Hospital/ Cardiology Department, London

S10 2RX

Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY