Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299884
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2005-09-09
Brief Title:
Atorvastatin Versus Ezetimibe and Fenofibrate as a Lipid-lowering Strategy
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
The Comparison of the Efficacy of Ezetimibe and Fenofibrate Versus Atorvastatin Alone in the Lowering of LDL Cholesterol
Status:
COMPLETED
Status Verified Date:
2016-03
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 primary aim of this study is to evaluate the efficacy and non-inferiority of a lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate taken daily versus atorvastatin daily in lowering levels of low-density lipoprotein LDL-C cholesterol Additionally other aims would include effects on other types of blood cholesterol and examining the safety of the ezetimibe and fenofibrate regimen as compared to atorvastatin
Detailed Description:
It has been demonstrated in several previous primary and secondary studies that lowering low-density lipoprotein cholesterol LDL-C with the use of medications such as 3-hydroxy-3-methylglutaryl-coenzyme A HMG-CoA reductase inhibitors improves mortality and morbidity related to cardiovascular events in patients with hypercholesterolemia Such inhibitors which are known as statins act to block the synthesis of cholesterol in the liver These medications are generally well tolerated by the vast majority of patients but a small number experience side effects most seriously those of myopathies rhabdomyolysis and elevated liver enzymes - recognition of this fact that statins are not universally without problems highlights the need for viable alternatives
Ezetimibe is a relatively new medication in Canada approved for use in patients with cholesterol problems It is an intestinal cholesterol binder that is known to be well-tolerated with side effects similar to placebo Alone it has a modest effect in the lowering of LDL-C Fenofibrate is a medication that also works through the liver and has long been used to adjust blood lipid levels in patients with mixed lipid problems Alone it also has a modest effect in the lowering of LDL-C Recent study however has shown that the effect of ezetimibe and fenofibrate together in the lowering of LDL-C is greater than that of either drug alone This combination if as effective in this regard as atorvastatin would prove a valid alternative to the use of the atorvastatin in the lowering of LDL-C and a benefit for patients who have had problems tolerating statin therapy but still require medication for elevated cholesterol
Ezetimibe is a relatively new medication in Canada approved for use in patients with cholesterol problems It is an intestinal cholesterol binder that is known to be well-tolerated with side effects similar to placebo Alone it has a modest effect in the lowering of LDL-C Fenofibrate is a medication that also works through the liver and has long been used to adjust blood lipid levels in patients with mixed lipid problems Alone it also has a modest effect in the lowering of LDL-C Recent study however has shown that the effect of ezetimibe and fenofibrate together in the lowering of LDL-C is greater than that of either drug alone This combination if as effective in this regard as atorvastatin would prove a valid alternative to the use of the atorvastatin in the lowering of LDL-C and a benefit for patients who have had problems tolerating statin therapy but still require medication for elevated cholesterol
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