drugset / Trial / NCT01424891

Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe

NCT01424891

Completed 31 enrolled Heidelberg University
RandomizedParallel-groupDouble-blindTreatment

Summary

Lowering LDL cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the effects of newer cholesterol lowering agents such as ezetemibe with respect to their anti-inflammatory potential are less intensively studied. Therefore the investigators analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear cells (PBMCs) of patients with type 2 diabetes.

Timeline

Start
2004-04
Primary completion
2006-07
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ezetimibe Unknown 10 mg
Comparator Simvastatin Small molecule 10 mg
Comparator Simvastatin Small molecule 80 mg