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

Completed

• Conditions: Coronary Heart Disease

• Registration Number: NCT00134940
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-25
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-15
• Last Update Posted: 2011-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Novartis; 🇩🇪 Erlangen, Germany

Novarits; 🇦🇹 Graz, Austria

Novartis Investigative Site; 🇩🇪 Berlin, Germany