Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes
NCT ID: NCT01185236
Last Updated: 2010-08-19
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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UNKNOWN
PHASE4
132 participants
INTERVENTIONAL
2010-09-30
2011-08-31
Brief Summary
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DM2 patients will be screened for inclusion criteria. Patients (n=66 in each arm) will be randomized to either Ezetimibe/simvastatin 10/20mg or atorvastatin 20mg after 4 week washout or TLC period. Primary and secondary endpoints will be assessed at week 12.
Primary endpoint:
1\) change of ApoB/ApoA ratio at week 12.
Secondary endpoint:
1. Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.
2. Change of HbA1C at week 12.
3. Change of HOMA index at week 12
\- HOMA =\[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)\] / 22.5
4. Change of hsCRP at week 12
5. Safety assessment
Hypotheses:
* Three months treatment of Vytorin 10/20mg will be superior to atorvastatin 20mg in ApoB/ApoA ratio.
* In DM patients, Ezetimibe/Simvastatin Combination will be well-tolerated.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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simvastatin/ezetimibe (vytorin) group
vytorin 10/20mg po once daily for 12weeks
simvastatin/ezetimibe
simvastatin/ezetimibe 10/20mg once daily for 12weeks
atorvastatin group
atorvastatin 20mg po once daily for 12weeks
atorvastatin 20mg
atorvastatin 20mg once daily for 12weeks
Interventions
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simvastatin/ezetimibe
simvastatin/ezetimibe 10/20mg once daily for 12weeks
atorvastatin 20mg
atorvastatin 20mg once daily for 12weeks
Eligibility Criteria
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Inclusion Criteria
2. Hypercholesterolemia (baseline screening LDL-C \> 100 mg/dL)
3. In case of medication, stable doses of oral hypoglycemic agents for at least three months
4. HbA1c \<8.5%
5. Age: 20-80
Exclusion Criteria
2. Serious liver disease (\> x3 LFT UNL)
3. Congestive heart failure
4. Stroke or MI/coronary intervention during the preceding 3 months.
5. CK \> x 2.5 UNL
6. Unstable hypo/hyperthyroidism
7. Pregnant/lactating woman, or woman intending to become pregnant
8. Subject with any clinically significant condition or situation, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
20 Years
80 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Seoul ntional university hospital
Locations
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Seoul national university hospital
Seoul, , South Korea
Countries
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Central Contacts
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References
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Lee JH, Kang HJ, Kim HS, Sohn DW, Oh BH, Park YB. Effects of ezetimibe/simvastatin 10/20 mg vs. atorvastatin 20 mg on apolipoprotein B/apolipoprotein A1 in Korean patients with type 2 diabetes mellitus: results of a randomized controlled trial. Am J Cardiovasc Drugs. 2013 Oct;13(5):343-51. doi: 10.1007/s40256-013-0031-6.
Other Identifiers
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H-1007-100-324
Identifier Type: -
Identifier Source: org_study_id
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