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To investigate the safety and efficacy of K-877 Extended Release (ER) once daily for 52 weeks in the morning or evening in dyslipidema.The starting dose of the ER tablet will be 0.2 mg/day. If the efficacy is insufficient, it will investigate the safety and efficacy of 0.4 mg/day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| morning administration | Experimental | K-877 ER 0.2 mg/day morning administration (once daily) |
|
| evening administration | Experimental | K-877 ER 0.2 mg/day evening administration (once daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-877 ER 0.2 mg/day morning administration (once daily) | Drug | K-877 ER 0.2 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy : Mean of percent change from baseline in fasting serum TG (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation | Final evaluation (Week 52 or at discontinuation) and immediately before it |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy : Mean of percent change from baseline in fasting serum Total Cholesterol (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation | Final evaluation (Week 52 or at discontinuation) and immediately before it | |
| Efficacy : Mean of percent change from baseline in fasting serum LDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saiseikai Futsukaichi Hospital | Fukuoka | Japan | ||||
| National Hospital Organization Takasaki General Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39924184 | Result | Arai H, Yamashita S, Araki E, Yokote K, Tanigawa R, Saito A, Furukawa D, Suganami H, Ishibashi S. Long-Term Effects of Extended-Release Pemafibrate Tablets on Dyslipidemia and Safety in Triglyceridemic Patients: A Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group Study. J Atheroscler Thromb. 2025 Aug 1;32(8):1006-1026. doi: 10.5551/jat.65350. Epub 2025 Feb 7. |
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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 0.2 mg/day evening administration (once daily) | Drug | K-877 ER 0.2 mg tablet |
|
|
| Final evaluation (Week 52 or at discontinuation) and immediately before it |
| Efficacy : Mean of percent change from baseline in fasting serum HDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation | Final evaluation (Week 52 or at discontinuation) and immediately before it |
| Efficacy : Mean of percent change from baseline in fasting serum non-HDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation | Final evaluation (Week 52 or at discontinuation) and immediately before it |
| Gunma |
| Japan |
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