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NCT00134940 Clinical Trial

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

Coronary Heart Disease Clinical Trial

Official title:
A Non-interventional Protocol to Collect Prospective and Retrospective Data in Patients Receiving Everolimus to Prevent Acute Rejection Following Cardiac Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00134940
Other study ID # CRAD001A2424
Secondary ID
Status Completed
Phase Phase 4
First received August 23, 2005
Last updated June 15, 2011
Start date January 2005
Est. completion date November 2006

Study information
Verified date June 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Sweden: Swedish National Council on Medical EthicsGermany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Novarits Graz
Austria Novartis Investigative Site Innsbruck
Austria Novartis Wein
Germany Novartis Bad Oeynhausen
Germany Novartis Investigative Site Berlin
Germany Novartis Erlangen

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

Austria,  Germany, 

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