NCT04652349已完成3 期
A Randomized, Double-Blinded, Multi-center, Phase 3 Study to Evaluate Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 279 人开始时间: 2020年7月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- Percentage change(%) from baseline in LDL-C at week 8
研究概览
简要总结
The purpose of this study is to investigate the safety and clinical efficacy of HGP1910 and HCP1903 in patients with primary 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged ≥ 19 years
- •Participants who have voluntarily given written consent to participate in this clinical trial
- •Participants with LDL-C ≤ 250mg/dL and TG < 500mg/dL at Visit 1
- •Participants with LDL-C ≤ 250mg/dL, TG < 500 mg/dL and satisfied criteria according to cardiovascular risk category at Visit 2 (after at least 4 weeks of TLC)
排除标准
- •Patients with active liver disease and severe liver impairment
- •Patients with severe renal failure (eGFR < 30 mL/min/1.73 m2 at Visit 1)
- •Patients with type I diabetes or uncontrolled type 2 diabetes
- •Patients with acute hypertension or uncontrolled hypertension (sitSBP ≥ 180 mmHg or sitDBP ≥ 110 mmHg at Visit 1)
- •Patients with symptomatic orthostatic hypotension
- •Patients with NYHA class III~IV heart failure, CCSA class III~IV angina, ventricular arrhythmia, severe hemorrhagic or ischemic cerebrovascular diseases, transient ischemic attacks (TIAs), acute coronary syndrome or a history of angioplasty, percutaneous coronary intervention, or coronary artery bypass surgery within six months before Visit
- •Patients who were diagnosed with a malignant tumor within five years before Visit.
研究组 & 干预措施
HGP1910
Experimental
干预措施: HGP1910 (Drug)
HCP1903
Experimental
干预措施: HCP1903 (Drug)
HGP1909
Active Comparator
干预措施: HGP1909 (Drug)
HGP1911
Active Comparator
干预措施: HGP1911 (Drug)
结局指标
主要结局
Percentage change(%) from baseline in LDL-C at week 8
时间窗: baseline, 8 weeks
次要结局
- Percentage change(%) from baseline in LDL-C, TC, HDL-C, non-HDL-C(baseline, 4 weeks, 8 weeks)
- Percentage change(%) from baseline in Apo A1, Apo B, lipoprotein (a)(baseline, 4 weeks, 8 weeks)
- Percentage change(%) from baseline in LDL-C at week 4(baseline, 4 weeks)
- Proportion of subjects achieving LDL-C treatment goals by cardiovascular Risk Category(baseline, 4 weeks, 8 weeks)
研究者
研究点 (1)
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