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A multicenter, active-controlled, randomized, double-blind comparative study to compare the efficacy and safety of K-924 LD tablet or K-924 HD tablet to pitavastatin 2 mg or 4 mg in patienta with hypercholesterolemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K-924 LD | Experimental | K-924 LD tablet once daily |
|
| K-924 HD | Experimental | K-924 HD tablet once daily |
|
| Pitavastatin 2 mg | Active Comparator | K-924 LD Placebo tablet once daily |
|
| Pitavastatin 4 mg | Active Comparator | K-924 HD Placebo tablet once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-924 LD | Drug | Pitavastatin 2 mg / Ezetimibe 10 mg tables |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy : % change from baseline in LDL-C (Friedewald formula) (mg / dL) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy : % change or change from baseline in LDL-C (mg / dL) | From baseline upto week 12 | |
| Efficacy : % change or change from baseline in non-HDL-C (mg / dL) | From baseline upto week 12 | |
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Inclusion Criteria:
Patients with hypercholesterolemia had to be age 20 years or older at written informed consent (ICF)
Patients who have been on a diet and / or exercise regimen more than 12 weeks before the screening
Those whose LDL-C (Friedewald formula) at the screening any of the following in the category classification based on Japan Atherosclerosis Society guidelines for prevention Atherosclerotic Cardiovascular Disease 2017
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Heishinkai OCROM Clinic | Osaka | Japan | ||||
| Medical Corporation Heishinkai OPHAC Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36908150 | Result | Tsujita K, Yokote K, Ako J, Tanigawa R, Tajima S, Suganami H. Efficacy and Safety of Pitavastatin/Ezetimibe Fixed-Dose Combination vs. Pitavastatin: Phase III, Double-Blind, Randomized Controlled Trial. J Atheroscler Thromb. 2023 Nov 1;30(11):1580-1600. doi: 10.5551/jat.64006. Epub 2023 Mar 11. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| K-924 HD |
| Drug |
Pitavastatin 4 mg / Ezetimibe 10 mg tables |
|
| K-924 LD Placebo | Drug | Pitavastain 2 mg |
|
| K-924 HD Placebo | Drug | Pitavastain 4 mg |
|
| Efficacy : % change or change from baseline in HDL-C (mg / dL) |
| From baseline upto week 12 |
| Efficacy : % change or change from baseline in Total Cholesterol (mg / dL) | From baseline upto week 12 |
| Efficacy : % change or change from baseline in TG (mg / dL) | From baseline upto week 12 |
| Osaka |
| Japan |
| Medical Corporation Heishinkai ToCROM Clinic | Tokyo | Japan |
| D009750 |
| Nutritional and Metabolic Diseases |