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To investigate the efficacy and safety of K-877 Extended Release (ER) 0.2 mg/day or 0.4 mg/day (once daily) for 12 weeks in dyslipidemia, using K-877 Immediate Release (IR) 0.2 mg/day (twice daily) as a control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | K-877 ER 0.2 mg/day (once daily) |
|
| Treatment B | Experimental | K-877 ER 0.4 mg/day (once daily) |
|
| Control A | Active Comparator | K-877 IR 0.2 mg/day (twice daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-877 ER 0.2 mg/day (once daily) | Drug | K-877 ER 0.2 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy : % change from baseline in fasting serum TG (mg/dL) | 4, 8, and 12 week after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy : % change from baseline in fasting serum Total Cholesterol (mg/dL) | 4, 8, and 12 week after administration | |
| Efficacy : % change from baseline in fasting serum LDL-C (mg/dL) | 4, 8, and 12 week after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic | Kanagawa | Japan | ||||
| Medical Corporation Heishinkai OCROM Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38616112 | Result | Arai H, Yamashita S, Araki E, Yokote K, Tanigawa R, Saito A, Yamasaki S, Suganami H, Ishibashi S. Efficacy and Safety of Pemafibrate Extended-Release Tablet: a Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Comparison Trial. J Atheroscler Thromb. 2024 Nov 1;31(11):1517-1538. doi: 10.5551/jat.64677. Epub 2024 Apr 13. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C540740 | (R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid |
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| K-877 ER 0.4 mg/day (once daily) | Drug | K-877 ER 0.4 mg tablet |
|
|
| K-877 IR 0.2 mg/day (twice daily) | Drug | K-877 IR 0.1 mg tablet |
|
|
| Efficacy : % change from baseline in fasting serum HDL-C (mg/dL) | 4, 8, and 12 week after administration |
| Efficacy : % change from baseline in fasting serum non-HDL-C (mg/dL) | 4, 8, and 12 week after administration |
| Osaka |
| Japan |
| Dojinkinenkai Meiwa Hospital | Tokyo | Japan |
| Fukuwa Clinic | Tokyo | Japan |
| Ikebukuro Metropolitan Clinic | Tokyo | Japan |
| Medical Corp. Seikoukai New Medical Research System Clinic | Tokyo | Japan |
| Medical Corporation Asbo Tokyo Asbo Clinic | Tokyo | Japan |
| Medical Corporation Chiseikai Tokyo Center Clinic | Tokyo | Japan |
| Medical Corporation Heishinkai ToCROM Clinic | Tokyo | Japan |
| Medical Corporation Yuhokai Miho Clinic | Tokyo | Japan |
| Tokyo-Eki Center-building Clinic | Tokyo | Japan |