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This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and atorvastatin (Lipitor®) in high risk hypercholesterolemic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin | Experimental |
| |
| Atorvastatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | 2 mg QD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of LDL-C | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieving LDL-C < 100 mg/dL; the changes of HDL-C, TG, non-HDL-C, Apo A1 and Apo B, fasting plasma glucose, fasting insulin level, insulin resistance by the HOMA-IR, HbA1c, free fatty acid, and ADMA | Baseline to 4 weeks and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasmine Chao | Contact | +886-27423012 | jasmine@tanabe.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Jaw-Wen Chen, M.D. Ph.D. | Taipei Veterans General Hospital, Taipei, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Chang-hua | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25027585 | Derived | Lin LY, Huang CC, Chen JS, Wu TC, Leu HB, Huang PH, Chang TT, Lin SJ, Chen JW. Effects of pitavastatin versus atorvastatin on the peripheral endothelial progenitor cells and vascular endothelial growth factor in high-risk patients: a pilot prospective, double-blind, randomized study. Cardiovasc Diabetol. 2014 Jul 16;13:111. doi: 10.1186/s12933-014-0111-1. | |
| 24098467 |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Atorvastatin |
| Drug |
10 mg QD |
|
|
| National Cheng Kung University Hospital | Tainan | Taiwan |
|
| Chang Gung Memorial Hospital-LinKou | Taipei | Taiwan |
|
| National Taiwan University Hospital | Taipei | Taiwan |
|
| Taipei Veterans General Hospital | Taipei | Taiwan |
|
| Tri-Service General Hospital | Taipei | Taiwan |
| Liu PY, Lin LY, Lin HJ, Hsia CH, Hung YR, Yeh HI, Wu TC, Chen JY, Chien KL, Chen JW. Pitavastatin and Atorvastatin double-blind randomized comPArative study among hiGh-risk patients, including thOse with Type 2 diabetes mellitus, in Taiwan (PAPAGO-T Study). PLoS One. 2013 Oct 1;8(10):e76298. doi: 10.1371/journal.pone.0076298. eCollection 2013. |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |