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

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ClinicalTrials.gov Identifier: NCT00134940
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : June 16, 2011
Sponsor:
Information provided by:
Novartis

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 Secondary outcomes: safety


Condition or disease
Coronary Heart Disease

Study Type : Observational
Actual Enrollment : 100 participants
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
Study Start Date : January 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus
U.S. FDA Resources





Information from the National Library of Medicine

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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
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00134940     History of Changes
Other Study ID Numbers: CRAD001A2424
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 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
Arteriosclerosis
Arterial Occlusive Diseases
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs