NCT01424891

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• Inflammation

Interventions

Type	Name	Description
DRUG	Simvastatin 80 mg	treatment with 80 mg of simvastatin over a period of 8 weeks
DRUG	Sim10/Eze10	treatment with combination of simvastatin 10 mg and ezetimibe 10 mg
DRUG	Placebo	treatment with placebo over 8 weeks

Timeline

• Start date: 2004-04-01
• Primary completion: 2006-07-01
• Completion: 2011-08-01
• First posted: 2011-08-29
• Last updated: 2011-08-29

Locations

1 site across 1 country: Germany