Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H-0807-056-251 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dong-A Pharmaceutical | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There will be no significant differences in the efficacy and tolerability between the test and reference formulations of atorvastatin 20 mg in these Korean adults with primary hypercholesterolemia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipinon-test formulation of atrovastain - 20mg | Experimental |
| |
| Lipitor- branded formuation of atorvastatin-20mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin (Lipinon) | Drug | treatment of dyslipidemia administration : PO, qod |
|
| Measure | Description | Time Frame |
|---|---|---|
| the percent change of LDL-C level | After taken medication for 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the percent change in total cholesterol, triglyceride, high density lipoprotein cholesterol (HDL-C) level, apolipoprotein B/A1 ratio, LDL/HDL ratio, small dense LDL fraction, high-sensitive C reactive protein (hs-CRP) | After taken medication for 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23274145 | Derived | Kim SH, Seo MK, Yoon MH, Choi DH, Hong TJ, Kim HS. Assessment of the efficacy and tolerability of 2 formulations of atorvastatin in Korean adults with hypercholesterolemia: a multicenter, prospective, open-label, randomized trial. Clin Ther. 2013 Jan;35(1):77-86. doi: 10.1016/j.clinthera.2012.11.009. Epub 2012 Dec 28. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Atorvastatin (Lipitor) | Drug | treatment of dyslipidemia administration : PO, qod |
|
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D002318 | Cardiovascular Diseases |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
Not provided
Not provided
| 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 |
Not provided
Not provided