Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.

PHASE2CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Hypoplastic Left Heart SyndromeTricuspid AtresiaOther Specified Congenital Anomalies of Heart
Interventions
DRUG

Bosentan

tablets Bosentan 62,5 mg x 2 daily for two weeks, then 125 mg x 2 daily for 12 weeks

DRUG

Placebo

Placebo tablets 2 x daily for 2 weeks, then change to different placebo tablets to match Bosentan group, 2 x daily for 12 weeks

Trial Locations (4)

2100

Rigshospitalet, Copenhagen

8200

Aarhus University Hospital, Aarhus

Unknown

Lund University Hospital, Lund

Karolinska Institutet, Stockholm

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

collaborator

Bispebjerg Hospital

OTHER

collaborator

Actelion

INDUSTRY

lead

Rigshospitalet, Denmark

OTHER