SCHEDULE Follow Up Visit 5-7 yr

PHASE4CompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

January 18, 2016

Primary Completion Date

September 25, 2017

Study Completion Date

September 25, 2017

Conditions
Heart Transplantation
Interventions
DRUG

Everolimus

"All patients, independent of their initial randomization in the core study, were followed up as in one single group~Commercially available everolimus (Certican®), oral route, was used."

DRUG

Cyclosporine

Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3)

DRUG

Mycophenolate mofetil

Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11

DRUG

Corticosteroids

Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups.

Trial Locations (6)

DK-8200

Novartis Investigative Site, Århus N

DK-2100

Novartis Investigative Site, Copenhagen

0372

Novartis Investigative Site, Oslo

413 45

Novartis Investigative Site, Gothenburg

581 85

Novartis Investigative Site, Linköping

221 85

Novartis Investigative Site, Lund

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY