Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

August 14, 2017

Primary Completion Date

June 30, 2021

Study Completion Date

July 26, 2021

Conditions
Congenital Heart Disease
Interventions
DRUG

Macitentan 10 mg

film-coated tablet; oral use

DRUG

Placebo

film-coated tablet; oral use

Trial Locations (32)

100

National Taiwan University Hospital, Taipei

1640

Auckland City Hospital, Auckland

2050

Royal Prince Alfred Hospital, Camperdown

2100

Rigshospitalet Kardiologisk Klinisk, Copenhagen

2145

Westmead Hospital, Westmead

3052

Royal Children's Hospital, Parkville

4032

The Prince Charles Hospital, Adult Congenital Heart Disease Unit, Chermside

4101

Queensland CHILDREN'S HOSPITAL, South Brisbane

5000

Royal Adelaide Hospital, Adelaide

13353

Deutsches Herzzentrum Berlinklinik Für Angeborene Herzfehler, Berlin

33604

Hôpital Cardiologique Du Haut-Lévêque, Pessac

34295

CHU Arnaud de Villeneuve, Montpellier

43205

Nationwide Children's Hospital, Columbus

75015

Hôpital Necker - Enfants Malades, Paris

80636

Deutsches Herzzentrum München, München

90095

UCLA, Los Angeles

99202

Providence Medical Research Providence Health Care, Spokane

100029

Beijing Anzhen Hospital, Beijing

100037

Beijing Fuwai Hospital, Beijing

200127

Shanghai Childrens Medical Center, Shanghai

430022

Wuhan Asia Heart Hospital, Wuhan

35233-1935

University of Alabama at Birmingham, Birmingham

02114

Massachusetts General Hospital Heart Center, Boston

77030-2303

Texas Children's Hospital, Houston

G1V 4G2

CHU de Quebec Universite Laval, Québec

150 06

Fakultni nemocnice v Motole, Prague

80 952

Uniwersyteckie Centrum Kliniczne, Gdansk

30-663

Uniwersytecki Szpital Dzieciecy w Krakowie, Krakow

31 202

Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn, Krakow

51 124

Wojewodzki Szpital Specjalistyczny We Wroclawiu, Wroclaw

B15 2TH

Queen Elizabeth Hospital, Birmingham

B4 6NH

Birmingham Children's Hospital, Birmingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY