Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

January 9, 2009

Start Date ^†

August 2004

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00170859 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

Official Title ^†

A One-Year Multicenter, Randomized, Open-Label Study of the Safety and Efficacy of Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

Brief Summary

In this study two immunosuppressive regimens (everolimus in combination with cyclosporine microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose cyclosporine microemulsion are compared in maintenance heart transplant recipients with impaired renal function.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Heart Transplantation

Intervention ^†

Drug: Everolimus

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Recipients of primary heart transplant
Reduced renal function (serum creatinine > 1.7 ng/mL over 2 months or more) at 6 months or more after heart transplantation
Patients with current immunosuppressive therapy consisting of cyclosporine microemulsion and mycophenolate mofetil

Exclusion Criteria:

Patients who are recipients of multiple organ transplants
Patients who have previously received an organ transplant
Patients with serum creatinine > 3.5 mg/dl

Other protocol-defined exclusion criteria may apply.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Novartis

41 61 324 1111

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00170859

Responsible Party

External Affairs, Novartis Pharmaceuticals

Secondary IDs ^††

Study Sponsor ^†

Novartis Pharmaceuticals

Collaborators ^††

Investigators ^†

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.