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A Randomized, Double blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient with primary Hypercholesterolemia or Mixed Dyslipidemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DW1125 | Experimental | 1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily |
|
| DW1125A | Experimental | 1 Atorvastatin 5 mg tablet orally once daily |
|
| DW1125E | Placebo Comparator | 1 Ezetimibe 10mg tablet orally once daily |
|
| DW1125A-1 | Placebo Comparator | 1 Atorvastatin 10mg tablet orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe/Atorvastatin 10/5 mg | Drug | DW1125 |
| |
| Atorvastatin 5mg |
| Measure | Description | Time Frame |
|---|---|---|
| % Change of LDL-C | % Change of LDL-C in week 8 from baseline | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| % Change of LDL-C | % Change of LDL-C in week 4 from baseline | 4 weeks |
| % Change of Lipid parameters | % Change of Lipid parameters(TC, TG, HDL-C, Non-HDL-C, Apo A1, Apo B) in week 4 and week 8 respectively after administrating the treatment drugs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| Drug |
DW1125A |
|
| Ezetimibe 10mg | Drug | DW1125E |
|
|
| Atorvastatin 10mg | Drug | DW1125A-1 |
|
|
| DW1125 placebo | Drug | Ezetimibe/Atorvastatin 10/5 mg placebo |
|
| DW1125A placebo | Drug | Atorvastatin 5mg placebo |
|
| DW1125E placebo | Drug | Ezetimibe 10mg placebo |
|
| DW1125A-1 placebo | Drug | Atorvastatin 10mg placebo |
|
| 4 weeks and 8 weeks |
| LDL-C goal achievement rates | LDL-C goal achievement rates in week 4 and week 8 respectively after administrating the treatment drugs (goal achievement for LDL-C: low risk group: < 160 mg/dL, intermediate risk group: <130 mg/dL, high risk group: < 100 mg/dL, extreme risk group: < 70 mg/dL) | 4 weeks and 8 weeks |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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