Post-marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus
June 15, 2011 updated by: Novartis
A Non-interventional Protocol to Collect Prospective and Retrospective Data in Patients Receiving Everolimus to Prevent Acute Rejection Following Cardiac Transplantation
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
primary care clinic
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
August 23, 2005
First Submitted That Met QC Criteria
August 23, 2005
First Posted (Estimate)
August 25, 2005
Study Record Updates
Last Update Posted (Estimate)
June 16, 2011
Last Update Submitted That Met QC Criteria
June 15, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRAD001A2424
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.