Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214617
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2005-09-19
Brief Title:
Effect of Crestor on Lipoprotein Metabolism in Humans
Sponsor:
Foundation for Atlanta Veterans Education and Research Inc
Organization:
Foundation for Atlanta Veterans Education and Research Inc
Study Overview
Official Title:
Effect of Crestor on the Kinetics of Plasma Apolipoproteins Dose-Response Study
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
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:
The objective of this research is to understand how Crestor can effectively reduce the levels of the bad cholesterol LDL in blood It is hypothesized that with a low dose Crestor will facilitate the rate of removal of LDL from the blood At the higher dose the increased potency of Crestor is explained by a reduction in the production of LDL by the liver
Detailed Description:
Crestor has been demonstrated to be effective in reducing plasma LDL by 20 to 60 in a dose dependent fashion While the primary mechanism of action of this class of agents is the increase in the expression of LDL receptor resulting in accelerated clearance of LDL the increase potency of Crestor in comparison to other statins may suggest other mechanisms We propose to study the rate of incorporation of deuterated labeled leucine into VLDL apoB and LDL apoB and to determine the effect of two doses of Crestor 5 mgday and 40 mgday on the production and clearance of apoB Participants will be admitted to the General Clinical Research Center on three occasions 4 days 3 nights per admission for these metabolic studies This is an open-label study design to reflect usual care with the first admission taking place while the participant is not on any lipid-lowering therapy The second admission will occur after a minimum of 6 weeks on the low dose 5mgday The dose will be increased to 40 mgday at the time of discharge and the third admission will occur after a minimum of 6 weeks on the higher dose
A secondary objective of this study is to examine the rate of production and clearance of apoA-I the major protein in HDL at the 2 doses of Crestor In addition to a reduction in LDL Crestor has also been reported to result in a characteristic dose-dependent increase in HDL The mechanism of this increase is not understood
A secondary objective of this study is to examine the rate of production and clearance of apoA-I the major protein in HDL at the 2 doses of Crestor In addition to a reduction in LDL Crestor has also been reported to result in a characteristic dose-dependent increase in HDL The mechanism of this increase is not understood
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRUSROSU 0021 | None | None | None |