Not Signed In -
Organ Transplant |
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Clinical Trial: Efficacy and Safety of Everolimus in De Novo Heart Transplant Recipients.
This study is currently recruiting patients.
Verified by Novartis September 2005
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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 transplant recipient | Drug: Everolimus | Phase III |
MedlinePlus consumer health information
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:
Study start: December 2004
Eligibility
Ages Eligible for Study: 18 Years - 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)
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00150046
Basel Novartis Pharma AG 41 61 324 1111
Switzerland
Basel Novartis Pharma AG, Basel, Switzerland; Recruiting
Novartis Pharma AG 41 61 324 1111
Study chairs or principal investigators
Basel Novartis Pharma AG, Study Chair, Basel Novartis Pharma AG
More Information
Study ID Numbers: CRAD001A2411
Last Updated: September 7, 2005
Record first received: August 26, 2005
ClinicalTrials.gov Identifier: NCT00150046
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: August 26, 2005
ClinicalTrials.gov Identifier: NCT00150046
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- A Transplant Center//'s Dedicated Duo (Cleveland Clinic)
- Organ Donation and Transplantation (Cleveland Clinic)
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