NCT07623915尚未招募3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Bempedoic Acid in Patients With Hyperlipidemia Not Adequately Controlled by Statins
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 222
研究概览
简要总结
This trial is a multicenter randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. 18 years and older.
- •18.5 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m
- •Diagnosis with ASCVD or have high-risk ASCVD, and/or diagnosis with HeFH.4.Be on stable lipid-modifying therapy for at least 4 weeks prior to screening, including moderate to high-dose statins with or without other lipid-modifying therapy (cholesterol absorption inhibitors[ezetimibe, Hyzetimibe]，fibrates [except gemfibrozil]）; 5.Fasting LDL-C must meet any one of the following
- •For participants with high risk of ASCVD: LDL-C ≥ 2.6 mmol/L (or 100 mg/dL);
- •For participants with extremely high risk of ASCVD: LDL-C≥ 1.8 mmol/L (or 70 mg/dL); 3) For participants with ultra-high risk of ASCVD: LDL-C≥ 1.4 mmol/L (or 55 mg/dL).
- •6.Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form.
排除标准
- •Known allergy to any component of the investigational drug or its excipients or related preparations, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution.
- •Diagnosis with HoFH.
- •History of tendon diseases or tendon ruptures before the screening.
- •Severe, uncontrolled concomitant conditions that may affect drug absorption or have a significant impact on lipid level.
- •Hyperthyroidism or uncontrolled hypothyroidism
- •Uncontrolled hypertension
- •Severe cardiovascular or cerebrovascular events in the past 3 months
- •History of nephrotic syndrome or glomerulonephritis or severe renal dysfunction.
- •Liver disease or dysfunction
研究者
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