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| ID | Type | Description | Link |
|---|---|---|---|
| H-1002-038-309 | Other Identifier | Seoul National University Hospital |
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| Name | Class |
|---|---|
| Yuhan corp., Seoul, Korea | UNKNOWN |
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The generic formulation of atorvastatin (AtorvaĀ®) 20mg was not inferior to the branded formulation of atorvastatin (LipitorĀ®) 20mg in this 8-week treatment of hyperlipidemic Korean patients. In PP analysis, the LDL cholesterol goal achievement rate was significantly higher in Atorva group. Both treatments were well tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorva | Experimental | generic formulation (AtorvaĀ®) of atorvastatin 20mg once daily |
|
| Lipitor | Active Comparator | branded formulation (LipitorĀ®) of atorvastatin 20mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| generic formulation of atorvastatin (AtorvaĀ®) | Drug | Treatment with generic formulation of atorvastatin (AtorvaĀ®) once daily, for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| % change of LDL cholesterol | The difference in percent change of serum LDL cholesterol concentration between genericAtorva and Lipitor branded group | After 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| % change of other lipid paramenters(total cholesterol, high-density lipoprotein [HDL] cholesterol, triglyceride [TG], apolipoprotein B [ApoB] and apolipoprotein A1 [ApoA1]) | After 8 weeks of treatment | |
| % change of lipoprotein and apolipoprotein ratios (ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| branded formulation of atorvastatin (LipitorĀ®) | Drug | Treatment with branded formulation of atorvastatin (LipitorĀ®)once daily, for 8 weeks |
|
| After 8 weeks of treatment |
| Change of highly sensitive C-reactive protein (hsCRP) | After 8 weeks of treatment |
| LDL cholesterol goal achievement rate | LDL cholesterol goal achievement rate according to NECP-ATP III guideline | After 8 weeks of treatment |
| D009750 |
| Nutritional and Metabolic Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |