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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00134940
First received: August 23, 2005
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  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 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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

primary care clinic

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

No publications provided

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013