| Trial ID: | L6256 |
| Source ID: | NCT03403556
|
| Associated Drug: |
Rosuvamibe
|
| Title: |
High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Atherosclerotic Cardiovascular Disease|Type 2 Diabetes
|
| Interventions: |
DRUG: Rosuvamibe|DRUG: Monorova
|
| Outcome Measures: |
Primary: Mean percent change from baseline to week 24 in low-density lipoprotein cholesterol (LDL-C), Up to 24 weeks | Secondary: Proportion of subjects achieving < 7.5% 10-year ASCVD risk without withdrawn due to adverse events, Up to 24 weeks|Mean change from baseline to week 12 and to week 24 in 10-year ASCVD risk, Up to 12 weeks, Up to 24 weeks|Proportion of subjects achieving the comprehensive lipid target (LDL-C < 70mg/dL, Non-HDL-C < 100mg/dL, and Apolipoprotein B < 80mg/dL) without withdrawn due to adverse events, Up to 24 weeks|Mean change from baseline to week 24 in calculated LDL cholesterol(mg/dL), HDL cholesterol(mg/dL), Triglyceride(mg/dL), non-HDL cholesterol(mg/dL), Apolipoprotein B(mg/dL), Apolipoprotein A1(mg/dL), Up to 24 weeks|Mean change from baseline to week 24 in Hepatic Steatosis Index (HSI), hepatic steatosis index (HSI)= 8x(ALT/AST ratio)+BMI (+2, if female; +2, if diabetes mellitus), Up to 24 weeks|Mean change from baseline to week 24 in Fatty Liver Index (FLI), FLI scores will be calculated based on triglycerides, BMI, r-GT and Waist circumference. BMI(kg/m\^2) will be calculated based on height(m) and weight(kg)., Up to 24 weeks|Mean change from baseline to week 24 in non-alcoholic fatty liver disease liver fat score (NAFLD-LFS), Up to 24 weeks|Mean change from baseline to week 24 in HbA1c, Up to 24 weeks|Mean change from baseline to week 24 in fasting plasma glucose (FPG), Up to 24 weeks|Mean change from baseline to week 24 in sCD36, Up to 24 weeks|Mean change from baseline to week 24 in HOMA-IR, Up to 24 weeks|Mean change from baseline to week 24 in HOMA-B, Up to 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Yuhan Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
140
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2018-03-27
|
| Completion Date: |
2021-12
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-14
|
| Locations: |
Daegu Catholic University Medical Center, Daegu, Korea, Republic of|Keimyung University Dongsan Medical Center, Daegu, Korea, Republic of|Kyungpook National University Hospital, Daegu, Korea, Republic of|Yeungnam University Medical Center, Daegu, Korea, Republic of|The Catholic University of Korea, St. Vincent's Hospital, Gyeonggi-do, Korea, Republic of|Korea University Anam Hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT03403556
|
