Clinical Trial Details
| Trial ID: | L6650 |
| Source ID: | NCT03446261 |
| Associated Drug: | Rosuvamibe® Tab |
| Title: | Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus|Hypercholesterolemia |
| Interventions: | DRUG: Rosuvamibe® Tab|DRUG: Monorova® Tab |
| Outcome Measures: | Primary: Change from baseline to week 8 in ApoB/ApoA1 ratio, Baseline, Week 8 | Secondary: Proportion of over 50% reduction in LDL-C, Baseline, Week 8|Proportion of subjects achieving the comprehensive lipid target (LDL-C<70mg/dL, Non-HDL-C<100mg/dL, and ApoB<80mg/dL), Baseline, Week 8|Change from baseline to week 8 in total, non-HDL, LDL and HDL cholesterol, triglyceride, ApoB, ApoA1 and ApoB48, Baseline, Week 8|Change from baseline to week 8 in HOMA-IR, Baseline, Week 8|Change from baseline to week 8 in hs-CRP, Baseline, Week 8|Change from baseline to week 8 in HbA1C, Baseline, Week 8|Change from baseline to week 8 in FPG, Baseline, Week 8 |
| 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: | 2018-02-23 |
| Completion Date: | 2019-03-05 |
| Results First Posted: | |
| Last Update Posted: | 2019-07-23 |
| Locations: | Asan Medical Center, Kora-ri, Korea, Republic of|Asan Medical Center, Seoul, 05505, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT03446261 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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