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To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.
Randomly assigned to two groups (KI1106 or Atorvastatin monotherapy) after 4 weeks run-in period and prescribed KI1106 or Atorvastatin for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Group- KI1106 | Experimental | KI1106 tablet - daily administration |
|
| Control Group - Atorvastatin | Active Comparator | Atorvastatin Calcium 20mg - daily administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KI1106 4g, QD | Drug | KI1106 4 Capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Variation rate of Non HDL-C | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Variation rate of TG | 4 weeks, 8 weeks | |
| Variation rate of Non HDL-C | 4 weeks | |
| Variation rate of TC |
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Inclusion criteria:
Screening Visit
Baseline Visit
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| kyungshun Shin, Dr | manager | Study Director |
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| Atorvastatin Calcium 20mg, QD |
| Drug |
Atorvastatin Calcium 20mg |
|
| 4 weeks, 8 weeks |
| Variation rate of LDL-C | 4 weeks, 8 weeks |
| Variation rate of VLDL-C | 4 weeks, 8 weeks |
| Variation rate of Apo A-I | 4 weeks, 8 weeks |
| Variation rate of Apo B | 4 weeks, 8 weeks |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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