We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134940
First Posted: August 25, 2005
Last Update Posted: June 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

  Contacts and Locations
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
  More Information

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00134940     History of Changes
Other Study ID Numbers: CRAD001A2424
First Submitted: August 23, 2005
First Posted: August 25, 2005
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