Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451828
Status:
COMPLETED
Last Update Posted:
2011-10-05
First Post:
2007-03-23
Brief Title:
Cholesterol and Pharmacogenetic Study
Sponsor:
UCSF Benioff Childrens Hospital Oakland
Organization:
UCSF Benioff Childrens Hospital Oakland
Study Overview
Official Title:
Cholesterol and Pharmacogenetic Study
Status:
COMPLETED
Status Verified Date:
2011-10
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:
CAP
Brief Summary:
The overall objective of the CAP study was to determine genetic influences on efficacy of simvastatin treatment with regard to LDL cholesterol reduction and changes in other markers of cardiovascular disease risk
Detailed Description:
Despite widespread use of statin therapy for reducing risk of cardiovascular disease risk there is considerable inter-individual variation in statin efficacy and it would be desirable to identify markers that would be predictive of the magnitude of beneficial response The effect of statin most strongly associated with improved clinical outcomes is reduction in LDL cholesterol The CAP study was a six week non-randomized open label study of simvastatin 40 mgday in a group of 335 African-American and 609 Caucasian volunteer subjects Measurements of plasma lipids and lipoproteins as well as other markers of cardiovascular disease risk were obtained at the screening and entry visits and after four and six weeks of simvastatin treatment Both baseline measurements and changes in response to simvastatin therapy are being used to test for associations with genetic polymorphisms Significant findings are being replicated in other study cohorts
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