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

NCT01424891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2011-08-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Gottfried Rudofsky, MD · University Hospital of Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2006-07-31
Completion
2011-08-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01424891 on ClinicalTrials.gov