Status:
UNKNOWN
Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes Mellitus Without Insulin Treatment
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
A single center, open label, randomized, clinical trial comparing ApoB/ApoA ratio of Vytorin 10/20mg vs atorvastatin 20mg treatment. DM2 patients will be screened for inclusion criteria. Patients (n=...
Eligibility Criteria
Inclusion
- Type 2 DM
- Hypercholesterolemia (baseline screening LDL-C \> 100 mg/dL)
- In case of medication, stable doses of oral hypoglycemic agents for at least three months
- HbA1c \<8.5%
- Age: 20-80
Exclusion
- Chronic renal failure: creatinine \> 3.0 mg/dL
- Serious liver disease (\> x3 LFT UNL)
- Congestive heart failure
- Stroke or MI/coronary intervention during the preceding 3 months.
- CK \> x 2.5 UNL
- Unstable hypo/hyperthyroidism
- Pregnant/lactating woman, or woman intending to become pregnant
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01185236
Start Date
September 1 2010
End Date
August 1 2011
Last Update
August 19 2010
Active Locations (1)
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1
Seoul national university hospital
Seoul, South Korea, 110744