Post-Marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus - Full Text View

Post-Marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00134940

Purpose

The purpose of this observational protocol is to evaluate the use of everolimus in routine clinical practice for heart transplants.

Primary outcome measures: incidence of acute rejection episodes Secondary outcomes: safety

Condition	Phase
Coronary Heart Disease	Phase IV

MedlinePlus related topics:

Heart Diseases Heart Transplantation

ChemIDplus related topics:

Everolimus

U.S. FDA Resources

Study Type:	Observational
Study Design:	Other

Official Title:	A Non-Interventional Protocol to Collect Prospective and Retrospective Data in Patients Receiving Everolimus to Prevent Acute Rejection Following Cardiac Transplantation

Further study details as provided by Novartis:

Estimated Enrollment:	100
Study Start Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Cardiac transplant recipients
Discharged alive from hospital
Must be receiving everolimus

Exclusion Criteria:

Patients not treated with everolimus beginning within 2 weeks after receiving a heart transplant

Other inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134940

Locations


Austria

	Wein, Austria

	Innsbruck, Austria

	Graz, Austria

Germany

	Erlangen, Germany

	Bad Oeynhausen, Germany

	Berlin, Germany

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Study ID Numbers:	CRAD001A2424
First Received:	August 23, 2005
Last Updated:	October 25, 2007
ClinicalTrials.gov Identifier:	NCT00134940
Health Authority:	Sweden: Swedish National Council on Medical Ethics; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Transplantation, heart

Organ transplant

Study placed in the following topic categories:

Everolimus

Coronary Disease

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Ischemia

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2008