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To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.
A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Livalo 2mg, Ezetrol 10mg | Experimental | Pitavastatin 2mg, Ezetimibe 10mg |
|
| Livalo 2mg | Active Comparator | Pitavastatin 2mg |
|
| Livalo 4mg, Ezetrol 10mg | Experimental | Pitavastatin 4mg, Ezetimibe 10mg |
|
| Livalo 4mg | Active Comparator | Pitavastatin 4mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Livalo, Ezetrol | Drug | Pitavastatin+Ezetimibe Pitavastatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| % change in LDL-C level from baseline at Week 8 | change in LDL-C level | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL-C level from baseline at Week 4 and Week 8 | change in LDL-C level | Week 4 and Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| dongryeong lee, Manager | +82-2-840-6982 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangdong Sacred Heart Hospital | Seoul | Korea | 134-701 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36241463 | Derived | Jeong HS, Hong SJ, Cho JM, Han KH, Cha DH, Jo SH, Kang HJ, Choi SY, Choi CU, Cho EJ, Jeong YH, Gwon HC, Kim BK, Lee SY, Kim SH, Ahn JC, Hong YJ, Kim WS, Woo SI, Park TH, Han KR. A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia. Clin Ther. 2022 Oct;44(10):1310-1325. doi: 10.1016/j.clinthera.2022.09.001. Epub 2022 Oct 12. |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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