K-924 Phase III Confirmatory Study

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III, Multicenter, Randomized, Clinial Trial to Evaluate the Efficacy and Safety of K-924 in Patienta With Hypercholesterolemia.

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: K-924 LD
* Drug: K-924 HD
* Drug: K-924 LD Placebo
* Drug: K-924 HD Placebo


Participation Criteria
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Eligibility Criteria
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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 Low risk of primary prevention : LDL-C => 160 mg/dL Medium risk of primary prevention : LDL-C => 140 mg/dL High risk of primary prevention : LDL-C => 120 mg/dL Exclusion Criteria: Patients with a history of myopathy or rhabdomyolysis due to pitavastatin or ezetimibe Patients with a history of hypersensitivity due to pitavastatin or ezetimibe Patients with severe liver damage (Child Pugh Class B or higher) or biliary obstruction Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women who do not use specific contraceptive methods Patients whose CK is 3 times or more of the upper limit of the reference value at screening Patients whose AST and ALT is 2 times or more of the upper limit of the reference value at screening Patients wiht type 1 diabetes or uncontrolled type 2 diabetes as defined HbA1c 8% or more at screening Patients with uncontrolled hypertension as defined systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more at screening Patients with eGFR of less than 30 mL / min / 1.73 m² at screening or dialysis Patients with heart failure class III or higher according to NYHA cardiac function classification Patients with uncontrolled arrhythmia Patients with uncontrolled metabolic endocrine disease Patients with a history of coronary artery disease or patient with familial hypercholesterolemia Patients with malignant tumors or who are judged to have a high possibility of relapse Patients who have collected 200 mL or more within 4 weeks before screening, 400 mL or more of blood within 12 weeks for males or 16 weeks for females, or within 2 weeks for (Plasma component / platelet component) Persons with a history of severe drug allergy (anaphylactic shock, etc.) Patients who need contraindicated drugs during the study period after obtaining consent Patients with TG of 400 mg / dL or more at screening Patients who have LDL apheresis Patients with malabsorption or history, or who have undergone gastrointestinal surgery (excluding appendectomy, hernia treatment, etc.) that may affect absorption. Patients with Alcohol or drug addiction Patients who participate in other clinical trials within 16 weeks prior to study drug administration and who are administered non-placebo investigational drugs, or who participate in other clinical trials concurrently with this study Patients who have received K-924 Patients who judged to be inappropriate by the Investigator or Investigator

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-924 LD<br>K-924 LD tablet once daily | Drug: K-924 LD<br>* Pitavastatin 2 mg / Ezetimibe 10 mg tables<br>|
| Experimental: K-924 HD<br>K-924 HD tablet once daily | Drug: K-924 HD<br>* Pitavastatin 4 mg / Ezetimibe 10 mg tables<br>|
| Active Comparator: Pitavastatin 2 mg<br>K-924 LD Placebo tablet once daily | Drug: K-924 LD Placebo<br>* Pitavastain 2 mg<br>|
| Active Comparator: Pitavastatin 4 mg<br>K-924 HD Placebo tablet once daily | Drug: K-924 HD Placebo<br>* Pitavastain 4 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy : % change from baseline in LDL-C (Friedewald formula) (mg / dL) |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |