JPRN-jRCT2080225088已完成3 期
K-924 Phase III long term study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Patients with hypercholesterolemia had to be age 20 years or older at written informed consent (ICF)
- •(2) Patients who have been on a diet and / or exercise regimen more than 4 weeks before the screening
- •(3) Patients who have been receiving pitavastatin calcium 2 mg / day or pitavastatin calcium 4 mg / day at least 4 weeks prior to the screening
- •(4) 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
- •- Secondary prevention patients with a history of coronary artery disease : LDL-C => 100 mg / dL
- •- Secondary prevention patients with familial hypercholesterolemia or acute coronary syndrome, or diabetes with other high-risk conditions : LDL-C => 70 mg / d
排除标准
- •(1) Patients with a history of myopathy or rhabdomyolysis due to pitavastatin or ezetimibe
- •(2) Patients with a history of hypersensitivity due to pitavastatin or ezetimibe
- •(3) Patients with severe liver damage (Child Pugh Class B or higher) or biliary obstruction
- •(4) 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
- •(5) Patients whose CK is 3 times or more of the upper limit of the reference value at screening
- •(6) Patients whose AST and ALT is 2 times or more of the upper limit of the reference value at screening
- •(7) Patients wiht type 1 diabetes or uncontrolled type 2 diabetes as defined HbA1c 8 % or more at screening
- •(8) 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
- •(9) Patients with eGFR of less than 30 mL / min / 1.73 m2 at screening or dialysis
- •(10) Patients with heart failure class III or higher according to NYHA cardiac function classification
- •(11) Patients with uncontrolled arrhythmia
- •(12) Patients with uncontrolled metabolic endocrine disease
- •(13) Patients with malignant tumors or who are judged to have a high possibility of relapse
- •(14) Patients who developed acute coronary syndrome or stroke within 12 months before obtaining consent
- •(15) 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)
- •(16) Persons with a history of severe drug allergy (anaphylactic shock, etc.)
- •(17) Patients who need contraindicated drugs during the study period after obtaining consent
- •(18) Patients with TG of 400 mg / dL or more at screening
- •(19) Patients who have LDL apheresis
- •(20) Patients with malabsorption or history, or who have undergone gastrointestinal surgery (excluding appendectomy, hernia treatment, etc.) that may affect absorption.
- •(21) Patients with Alcohol or drug addiction
- •(22) 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
- •(23) Patients who have received K-924
- •(24) Patients who judged to be inappropriate by the Investigator or Investigator
研究者
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