Viewing Study NCT00421005


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Study NCT ID: NCT00421005
Status: UNKNOWN
Last Update Posted: 2009-04-29
First Post: 2007-01-09
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Fluvastatin After Heart Transplantation
Sponsor: University of Bologna
Organization:

Study Overview

Official Title: Safety and Efficacy of Fluvastatin in Heart Transplant Recipients
Status: UNKNOWN
Status Verified Date: 2009-04
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Statin therapy is a treatment with a proven positive impact on survival after heart transplantation. However, it is unclear whether the beneficial effect of this class of drugs depends solely on their LDL-lowering properties or on anti-inflammatory and immuno-modulatory properties. Thus, this study was designed to compare safety and efficacy of two different strategies: 1. high fixed statin dose vs. 2. low starting dose with LDL-driven doses adjustments.
Detailed Description: None

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: