Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477204
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2007-05-21
Brief Title:
Clinical Trial of Zocor Simvastatin and Vytorin EzetimibeSimvastatin in Adolescents With Type 1 Diabetes
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2020-10
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:
None
Brief Summary:
The purpose of the study is to establish the safety of ezetimibesimvastatin and simvastatin in adolescents with Type 1 Diabetes and to determine the amount of decrease in LDL-cholesterolThe study hypothesizes that simvastatin and ezetimibesimvastatin will be safe in adolescents with Type 1 Diabetes and will lower LDL-cholesterol at 6 months
Detailed Description:
Cardiovascular disease is the leading cause of death in people with type 1 diabetes mellitus T1DM and since atherosclerosis begins in childhood data to inform clinicians as to appropriate dyslipidemia treatment in this high-risk population are of great public health importance In this trial of lipid-lowering medications Zocor simvastatin a statin compared to Vytorin ezetimibesimvastatin a combination of a statin and Zetia a medication that blocks cholesterol absorption will be performed in patients ages 12-18 years with LDL 130 mgdl consistent with current ADA guidelines The study hypothesizes that Zocor and Vytorin will be safe in adolescents with T1DM and will lower LDL-cholesterol at 6 months compared to baseline In a two-arm design Vytorin will lower LDL-c more than monotherapy with Zocor
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 |
|---|---|---|---|
| K23DK075360 | NIH | None | httpsreporternihgovquickSearchK23DK075360 |