Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe
NCT ID: NCT01424891
Last Updated: 2011-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2004-04-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Treatment with placebo over 8 weeks
Placebo
treatment with placebo over 8 weeks
Simvastatin 80 mg
treatment with 80 mg of simvastatin over 8 weeks
Simvastatin 80 mg
treatment with 80 mg of simvastatin over a period of 8 weeks
Sim10/Eze10
treatment with 10 mg of simvastatin in combination with 10 mg ezetimibe over 8 weeks
Sim10/Eze10
treatment with combination of simvastatin 10 mg and ezetimibe 10 mg
Interventions
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Simvastatin 80 mg
treatment with 80 mg of simvastatin over a period of 8 weeks
Sim10/Eze10
treatment with combination of simvastatin 10 mg and ezetimibe 10 mg
Placebo
treatment with placebo over 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes
* HbA1c value between 6.0 % and 9.0 %
* elevated LDL-c values \> 100 mg/dl with no lipid lowering treatment within the last six month
Exclusion Criteria
35 Years
80 Years
ALL
No
Sponsors
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Heidelberg University
OTHER
Responsible Party
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Gottfried Rudofsky
Principal investigator
Principal Investigators
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Gottfried Rudofsky, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Heidelberg
Locations
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University Hospital of Heidelberg
Heidelberg, , Germany
Countries
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Other Identifiers
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SimEze
Identifier Type: -
Identifier Source: org_study_id
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