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Register:	ClinicalTrials.gov
Last refreshed on:	28 November 2016
Main ID:	NCT00170859
Date of registration:	09/09/2005
Prospective Registration:	No
Primary sponsor:	Novartis Pharmaceuticals
Public title:	Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients
Scientific 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
Date of first enrolment:	August 2004
Target sample size:
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00170859
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Phase:	Phase 4

Countries of recruitment
Germany	Switzerland

Contacts

Name:	Novartis
Address:
Telephone:
Email:
Affiliation:	Novartis

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Heart Transplantation

Intervention(s)

Drug: Everolimus

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

CRAD001ADE01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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