Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection

PHASE3CompletedINTERVENTIONAL
Enrollment

721

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

July 31, 2011

Study Completion Date

July 31, 2011

Conditions
Graft Rejection
Interventions
DRUG

everolimus

Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.

DRUG

mycophenolate mofetil

Mycophenolate mofetil supplied as 500 mg tablets.

DRUG

cyclosporine

Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.

DRUG

corticosteroids

Corticosteroids standard dose.

Trial Locations (64)

53792

University of Wisconsin - Madison Medical School, Madison

77030

Methodist Hospital/DeBakey Heart Failure Research Center, Houston

Unknown

UCLA Medical Center, Los Angeles

California Pacific Medical Center, San Francisco

Stanford U Sch, Falk Cardiovasular Research Ctr., Stanford

University of Florida Shands Hospital, Gainesville

Emory University Hospital, Atlanta

Loyola Univerisity Medical School, Maywood

Massachusetts General Hospital, Boston

Tufts Medical Center, Boston

University of Michigan Health System, Ann Arbor

Washington University School of Medicine, St Louis

Columbia University Medical Center, New York

Recanati Miller Transplant Institute, New York

UNC Division of Cardiology, Chapel Hill

Duke University Heart Failure Research, Durham

Cleveland Clinic Foundation, Cleveland

Penn State College of Medicine, Hershey

Hahnemann University Hospital, Philadelphia

Temple University Hospital, Philadelphia

Thomas Jefferson University Hospital, Philadelphia

Medical University of South Carolina, Charleston

Texas Cardiovascular Consultants, Austin

University of Texas Medical Branch, Div of Cardio Thoracic, Galveston

Intermountain Medical Center, Murray

St. Luke's Medical Center Cardiac Services, Milwakee

Sanatorio Parque, Rosario

Fundacion Favalaro, Buenos Aires

St Vincents Hospital, Darlinghurst

Prince Charles Hospital, Chermside

Royal Perth Hospital, Perth

Universitaet Wien, Vienna

Cliniques Universitaires Saint-Luc, Brussels

University of Alberta Hospital, Edmonton

St Paul's Hospital, Vancouver

New Halifax Infirmary, Halifax

Toronto General Hospital, Toronto

Institut Univ. de cardiologie et pneumologie de Quebec, Sainte-Foy

Hopital Cardiologique de Lyon, Lyon

Hopital Georges Pompidou, Paris

Hopital Pitie Salpetriere, Paris

CHU de Strasbourg Hopital Civil Medicale B, Strasbourg

CHU Hopital de Brabois, Vandœuvre-lès-Nancy

Herz- u. Diabeteszentrum NRW/Ruhr-Univ. Bochum, Bad Oeynhausen

Deutsches Herzzentrum Berlin, Berlin

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

Kliniken der Med. Hochschule, Hanover

Universitaetsklinikum Kiel, Kiel

Universitaetsklinik Regensburg, Regensburg

Az. Osp. di Bologna Policl. S. Orsola-Malpighi Univ. degli Studi, Bologna

Azienda Ospedaliera G. Brotzu, Cagliari

A.O.-Universita di Padova-Universita degli Studi, Padua

Fodazione IRCCS Policlinico S. Matteo, Pavia

Azienda Ospedaliera S. Camillo-Forlanini, Roma

Az. Ospedaliero-Universitaria S. Giovanni Battista di Torino, Torino

Auckland Hospital, Auckland

Rikshospitalet, Hjertemedisinskavdeling, Oslo

Cardiovascular Center of Puerto Rico and the Caribbean, San Juan

Hospital Universitario Reina Sofia, Córdoba

Hospital Puerta de Hierro Majadahonda, Madrid

National Taiwan University Hospital, Taipei

Queen Elizabeth Hospital, Birmingham

Papworth Hospital, Cambridge

Wythenshawe Hospital, Manchester

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY