NCT04289649已完成3 期
A Phase III, Multicenter, Randomized, Clinial Trial to Evaluate the Efficacy and Safety of K-924 in Patienta With Hypercholesterolemia.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 3
- 主要终点
- Efficacy : % change from baseline in LDL-C (Friedewald formula) (mg / dL)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
K-924 LD
Experimental
K-924 LD tablet once daily
干预措施: K-924 LD (Drug)
K-924 HD
Experimental
K-924 HD tablet once daily
干预措施: K-924 HD (Drug)
Pitavastatin 2 mg
Active Comparator
K-924 LD Placebo tablet once daily
干预措施: K-924 LD Placebo (Drug)
Pitavastatin 4 mg
Active Comparator
K-924 HD Placebo tablet once daily
干预措施: K-924 HD Placebo (Drug)
结局指标
主要结局
Efficacy : % change from baseline in LDL-C (Friedewald formula) (mg / dL)
时间窗: Week 12
次要结局
- Efficacy : % change or change from baseline in HDL-C (mg / dL)(From baseline upto week 12)
- 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 Total Cholesterol (mg / dL)(From baseline upto week 12)
- Efficacy : % change or change from baseline in TG (mg / dL)(From baseline upto week 12)
研究者
研究点 (3)
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