Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00150046|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 2, 2011
This study will test the safety and efficacy of everolimus on heart transplant recipients.
This study is not recruiting in the United States.
|Condition or disease||Intervention/treatment||Phase|
|Heart Transplantation||Drug: Everolimus||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 12-month, Multicenter, Randomized, Open-label Non-inferiority Study of Renal Function and Efficacy Comparing Concentration-controlled Certican (1.5 mg/Day Starting Dose) With Reduced Neoral Dose Versus MMF With Standard Neoral Dose in de Novo Heart Transplant Recipients|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||May 2007|
- compare renal function
- compare rates of acute rejection, efficacy and safety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150046
|Novartis Investigational Site|
|Basel Novartis Pharma AG|
|Study Chair:||Basel Novartis Pharma AG||Basel Novartis Pharma AG|