Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients

This study is currently recruiting participants.

Verified by Novartis, December 2008

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00150046

Purpose

This study will test the safety and efficacy of everolimus on heart transplant recipients.

This study is not recruiting in the United States.

Condition	Intervention	Phase
Heart Transplantation	Drug: Everolimus	Phase III

MedlinePlus related topics: Heart Transplantation

Drug Information available for: Everolimus

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients

Further study details as provided by Novartis:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	176
Study Start Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male or female cardiac recipients 18-65 years of age undergoing primary heart transplantation. The graft must be functional at the time of randomization.
Calculated creatinine clearance (Cockroft-Gault) ≥ 50 mL/min at screening.
Patients who have given written informed consent to participate in the study.

Exclusion Criteria:

Patients who are recipients of multiple solid organ transplants or have previously received organ transplants
Patients with panel reactive antibodies > 20%.
Patients who are recipients of ABO incompatible transplants
Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150046

Contacts

Contact: Basel Novartis Pharma AG

41 61 324 1111

Locations

Germany
Novartis Investigational Site	Recruiting
Germany, Germany
Switzerland
Basel Novartis Pharma AG	Recruiting
Basel, Switzerland
Contact: Novartis Pharma AG 41 61 324 1111

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Chair:

Basel Novartis Pharma AG

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CRAD001A2411
Study First Received:	August 26, 2005
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00150046
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:

Heart transplantation
Everolimus
Heart transplant recipient

Study placed in the following topic categories:

Everolimus

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009