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Clinical Trial Details

Trial ID: L3925
Source ID: NCT03597412
Associated Drug: Rosuvamibe
Title: Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM
Acronym: MIRA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Atherosclerotic Cardiovascular Disease|Type 2 Diabetes Mellitus
Interventions: DRUG: Rosuvamibe|DRUG: Monorova
Outcome Measures: Primary: Change from baseline to week 24 in LDL-C level, Baseline, Week 24 | Secondary: Change from baseline to week 12 in LDL-C level, Baseline, Week 12|Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), Baseline, Week 12, Week 24|Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP), Baseline, Week 12, Week 24|Change from baseline to week 12 and week 24 in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein B48, and Apolipoprotein B/Apolipoprotein A1, Baseline, Week 24|Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c), Baseline, Week 12, Week 24|Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG), Baseline, Week 12, Week 24|Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR), Baseline, Week 12, Week 24|Proportion of subjects achieving LDL-C < 70mg/dL, Baseline, Week 12, Week 24|Proportion of subjects achieving LDL-C < 55mg/dL, Baseline, Week 12, Week 24|Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event), Up to 24 weeks
Sponsor/Collaborators: Sponsor: Yuhan Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 236
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-10-17
Completion Date: 2020-08-12
Results First Posted:
Last Update Posted: 2020-12-14
Locations: Kangbuk Samsung Hospital, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03597412