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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: August 23, 2005
Last updated: June 15, 2011
Last verified: June 2011

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 4

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Non-interventional Protocol to Collect Prospective and Retrospective Data in Patients Receiving Everolimus to Prevent Acute Rejection Following Cardiac Transplantation

Resource links provided by NLM:

Further study details as provided by Novartis:

Enrollment: 100
Study Start Date: January 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary care clinic

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
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Please refer to this study by its identifier: NCT00134940

Graz, Austria
Novartis Investigative Site
Innsbruck, Austria
Wein, Austria
Bad Oeynhausen, Germany
Novartis Investigative Site
Berlin, Germany
Erlangen, Germany
Sponsors and Collaborators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: External Affairs, Novartis Identifier: NCT00134940     History of Changes
Other Study ID Numbers: CRAD001A2424
Study First Received: August 23, 2005
Last Updated: June 15, 2011

Keywords provided by Novartis:
Transplantation, heart
Organ transplant

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on August 23, 2017