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The purpose of this study is to evaluate the efficacy and safety of Pitavastatin versus Pitavastatin/Fenofibrate in complex-dyslipidemia patients.
The purpose of this study is to demonstrate the efficacy of the Pitavastatin/Fenofibrate in complex-dyslipidemia patients by the reduction of non-HDL-Cholesterol levels compared with Pitavastatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL-PIF cap.160/2mg + Placebo | Experimental |
|
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| Livalo tab. 2mg + Placebo | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL-PIF cap.160/2mg + Placebo | Drug | Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean percentage change of Non-HDL Cholesterol | Change rate of Non-HDL-C after 8 weeks compared to baseline (%) | from baseline at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The mean percentage change of Non-HDL Cholesterol | Change rate of Non-HDL-C after 4 weeks compared to baseline (%) | from baseline at week 4 |
| The mean percentage change of LDL-C | Change rate of LDL-C after 4 and 8 weeks compared to baseline (%) |
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Inclusion Criteria:
High risk patient to Coronary Heart Disease
At visit 1(Screening)
LDL-C<100mg/dL and 150mg/dL≤TG<500mg/dL after 4 weeks of Pitavastatin 2mg monotherapy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki-Bae Seung | The Catholic University of Korea | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32891418 | Derived | Ihm SH, Chung WB, Lee JM, Hwang BH, Yoo KD, Her SH, Song WH, Chae IH, Park TH, Kim JH, Jeon DW, Cho BR, Kang SH, Park SD, Lee JB, Woo JT, Lee BW, Han KA, Won KH, Kim HS, Yu JM, Chung CH, Kim HJ, Cho HC, Seung KB. Efficacy and Tolerability of Pitavastatin Versus Pitavastatin/Fenofibrate in High-risk Korean Patients with Mixed Dyslipidemia: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial. Clin Ther. 2020 Oct;42(10):2021-2035.e3. doi: 10.1016/j.clinthera.2020.08.002. Epub 2020 Sep 2. |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| C108475 | pitavastatin |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Livalo tab. 2mg + Placebo | Drug | Pitavastatin ca 2mg |
|
|
| from baseline at week 4,8 |
| The mean percentage change of HDL-C | Change rate of HDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 |
| The mean percentage change of LDL-C/HDL-C | Change rate of LDL-C/HDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 |
| The mean percentage change of TC/HDL-C | Change rate of TC/HDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 |
| The mean percentage change of non-HDL-C/HDL-C | Change rate of non-HDL-C/HDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 |
| The mean percentage change of VLDL-C | Change rate of VLDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 |
| The mean percentage change of TG | Change rate of TG after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 |
| The mean percentage change of TC | Change rate of TC after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 |
| The mean percentage change of Apo Al | Change rate of Apo Al after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 |
| The mean percentage change of Apo B | Change rate of Apo B change after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 |
| The mean percentage change of Apo Al/Apo B | Change rate of Apo Al/Apo B after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 |
| The mean percentage change of fibrinogen | Change rate of fibrinogen after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 |
| The mean percentage change of hs-CRP | Change rate of hs-CRP after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 |
| Achievement rate(%) of treatment goals after 4 weeks and 8 weeks | LDL-C<100mg/dL & non-HDL-C <130mg/dL | from baseline at week 4,8 |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |