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

NCT ID: NCT00134940

Last Updated: 2011-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Coronary Heart Disease

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Novarits

Graz, , Austria

Site Status

Novartis Investigative Site

Innsbruck, , Austria

Site Status

Novartis

Wein, , Austria

Site Status

Novartis

Bad Oeynhausen, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis

Erlangen, , Germany

Site Status

Countries

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Austria Germany

Other Identifiers

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CRAD001A2424

Identifier Type: -

Identifier Source: org_study_id

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