Status:

COMPLETED

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

Lead Sponsor:

Novartis

Conditions:

Coronary Heart Disease

Eligibility:

All Genders

18-65 years

Brief Summary

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 Sec...

Eligibility Criteria

Inclusion

  • Cardiac transplant recipients
  • Discharged alive from hospital
  • Must be receiving everolimus

Exclusion

  • Patients not treated with everolimus beginning within 2 weeks after receiving a heart transplant
  • Other inclusion/exclusion criteria may apply.

Key Trial Info

Start Date :

January 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 1 2006

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00134940

Start Date

January 1 2005

End Date

November 1 2006

Last Update

June 16 2011

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Novarits

Graz, Austria

2

Novartis Investigative Site

Innsbruck, Austria

3

Novartis

Wein, Austria

4

Novartis

Bad Oeynhausen, Germany