An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.

PHASE3TerminatedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

April 11, 2019

Primary Completion Date

January 18, 2022

Study Completion Date

January 18, 2022

Conditions
Congenital Heart Disease With Fontan Circulation
Interventions
DRUG

macitentan 10 mg

macitentan 10 mg, film-coated tablet, oral use

Trial Locations (19)

1640

Auckland City Hospital, Auckland

2050

Royal Prince Alfred Hospital, Camperdown

2100

Rigshospitalet Kardiologisk Klinisk, Copenhagen

3052

Royal Children's Hospital, Parkville

4032

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

5000

Royal Adelaide Hospital, Adelaide

10002

National Taiwan University Hospital, Taipei

33604

Hôpital Cardiologique Du Haut-Lévêque, Pessac

75015

Hôpital Necker - Enfants Malades, Paris

99202

Providence Medical Research Providence Health Care, Spokane

100029

Beijing Anzhen Hospital, Beijing

200127

Shanghai Children's Medical Center, Shanghai

02114

Massachusetts General Hospital Heart Center, Boston

G1V 4G2

CHU de Québec Université Laval, Québec

150 06

Fakultni nemocnice v Motole, Prague

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

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

All Listed Sponsors
collaborator

Covance

INDUSTRY

collaborator

Henry Ford Health System

OTHER

collaborator

Almac Clinical Technologies

INDUSTRY

collaborator

ActiGraph LLC

OTHER

collaborator

Medidata Solutions

INDUSTRY

lead

Actelion

INDUSTRY