Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM
NCT ID: NCT03597412
Last Updated: 2020-12-14
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
236 participants
INTERVENTIONAL
2018-10-17
2020-08-12
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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Rosuvamibe Tab
Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks
Rosuvamibe
Rosuvastatin 10mg/Ezetimibe 10mg
Monorova Tab
Rosuvastatin 20mg qd for 24 weeks
Monorova
Rosuvastatin 20mg
Interventions
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Rosuvamibe
Rosuvastatin 10mg/Ezetimibe 10mg
Monorova
Rosuvastatin 20mg
Eligibility Criteria
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Inclusion Criteria
2. Patient with type 2 diabetes taking oral diabetes medication for at least 3 months
3. Patient diagnosed with ASCVD
* Myocardial Infarction (MI)
* Acute coronary syndrome (ACS)
* History of Coronary revascularization(Percutaneous Coronary Intervention, PCI)
* History of Coronary artery bypass graft surgery (CABG) or other arterial revascularization procedures
* Stroke or Transient ischemic attack (TIA)
* Peripheral Arterial Disease (PAD)
* Stable Angina
4. Written informed consent
Exclusion Criteria
2. HbA1c \> 8.5% at screening
3. Fasting triglyceride ≥ 400 mg/dL at screening
4. History of muscular disease or rhabdomyolysis due to use of statin
5. Hypersensitive to rosuvastatin or ezetemibe
6. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:
① Severe renal disease (CrCL \< 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) \< 30mL/min/1.73m2)
② ALT, AST \> 3x ULN or history of active liver disease
③ CPK \> 3x ULN
7. Those participating in clinical trials of other drugs
8. Other than the above who is deemed to be ineligible to participate in the trial by investigator
19 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Locations
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Kangbuk Samsung Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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YMC038
Identifier Type: -
Identifier Source: org_study_id