A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia
NCT ID: NCT03217409
Last Updated: 2019-09-23
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
PHASE4
85 participants
INTERVENTIONAL
2017-08-10
2019-05-23
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
NONE
Study Groups
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Rosuvastatin+Ezetimibe
Rosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week
Rosuvastatin+Ezetimibe
Rosuvastatin 5mg+Ezetimibe 10mg
Rosuvastatin
Rosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week
Rosuvastatin
Rosuvastatin 5Mg Tablet
Interventions
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Rosuvastatin+Ezetimibe
Rosuvastatin 5mg+Ezetimibe 10mg
Rosuvastatin
Rosuvastatin 5Mg Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects undergoing treatment for type 2 diabetes
* Subjects undergoing treatment of statin for hypercholesterolemia
* Fasting LDL-C ≤ 250mg/dL at the screening visit
* Fasting LDL-C ≥70mg/dL or ≤ 160mg/dL at the randomization visit
* Fasting TG\<500mg/dL
Exclusion Criteria
* Subjects with severe kidney disease
* Subjects with HIV positive result at the screening
* Pregnant or breast-feeding subjects
* Subjects with taking any medication affecting level of LDL (Fenofibrate, Omega 3 fatty aicd etc.)
* Insulin-treated Subjects
* Other exclusions applied
19 Years
75 Years
ALL
No
Sponsors
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Linical Korea
INDUSTRY
Yuhan Corporation
INDUSTRY
Responsible Party
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Locations
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Soon Chun Hyang University Hospital Cheonan
Cheonan, , South Korea
Soon Chun Hyang University Hospital Gumi
Gumi, , South Korea
Soon Chun Hyang University Hospital Bucheon
Gyeonggi-do, , South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, , South Korea
Countries
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Other Identifiers
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YMC022
Identifier Type: -
Identifier Source: org_study_id
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