Multi-center,Randomized,Double Blind,Placebo Controlled,Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 374
- 主要终点
- LDL-C
研究概览
简要总结
To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period of treatment in adults with primary hypercholesterolemia;
To determine the safety of HS-25 (20mg) in subjects with LDL-C
详细描述
This is a 12-week, randomized, double-blind, placebo-controlled study designed to assess the effects of the cholesterol absorption inhibitor HS-25 on LDL-C levels in adults who have untreated LDL-C levels ranging from 3.36-4.88mmol/L(130-189 mg/dL)and fasting triglyceride levels < 350 mg/dL. Eligibility is restricted to 18-75 years old men or women who are using a highly effective birth control method or are not of childbearing potential. Patients with diabetes, a history of myocardial infarction or other clinical evidence of atherosclerotic vascular disease are not eligible for participation in the study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are 18 to 75 years of age, male or female using a highly effective birth control method or not of child-bearing potential, at Visit 1 (screening visit).
- •LDL-C 130 to 189 mg/dL (inclusive) on a cholesterol lowering diet but no lipid modifying drug treatment for at least 6 weeks.
- •A qualifying LDL-C value must be obtained at the beginning and end of the placebo run-in (Visit 2 and Visit 3) and the Visit 3 value must be within 12% of the value at Visit 2, higher or lower; the average of both qualifying values must be in the range of 130 to 189 mg/dL (inclusive) for inclusion in the study.
- •TG ≤ 350 mg/dL on a cholesterol lowering diet but no lipid modifying drug treatment for at least 6 weeks and TG levels must be ≤ 350 mg/dL at both Visit 2 and Visit 3
- •Signed written informed consent.
排除标准
- •Liver transaminases > 1.5 x upper limit of normal.
- •Homozygous Familial Hypercholesterolemia.
- •Subject who was diagnosed as diabetes with aged greater than 40 years old.
- •Subject who was diagnosed as diabetes with one of the following of cardiovascular risk factorss: Hypertention Bp ≥ 140/90mmHg,or smoking, or low HDL-C (1.04mmol/L), or BMI≥28kg/m
- •Women who are pregnant or breast feeding.
- •Atherosclerotic cardiovascular disease including Arteriosclerotic heart disease, Acute coronary syndrome，Coronary artery bypass graft,Coronary angioplastyPeripheral arteriosclerosis,Cerebrovascular accident
- •history of Severe Endiocrine disease (for example Thyroid function abnormal)
- •History of a positive test for human immunodeficiency virus, hepatitis B or hepatitis C.
- •History of advanced cancer
- •Arrhythmias need to be treated by medications
- •Had severe injured or surgery in 6 months before study start.
- •Hypersensitive to HS-25 or place.
- •History of intolerance to ezetimibe.
- •Participation other studies in three months.
- •Treatment with a fibric acid derivative (eg, fenofibrate, gemfibrozil), probucol, warfarin, systemic corticosteroid, cyclosporine or other immunosuppressant agent within the prior 12 weeks.
研究组 & 干预措施
HS-25
20mg, QD, 12 weeks
干预措施: HS-25 (Drug)
Placebo of HS-25
20mg, QD, 12 weeks
干预措施: HS-25 (Drug)
Placebo of HS-25
20mg, QD, 12 weeks
干预措施: Placebo of HS-25 (Drug)
结局指标
主要结局
LDL-C
时间窗: 2,4,8,12,18,24,38,52 weeks
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
次要结局
- Non-HDL-C(2,4,8,12,18,24,38,52 weeks)
- HDL-C(2,4,8,12,18,24,38,52 weeks)
- TC(2,4,8,12,18,24,38,52 weeks)
- TG(2,4,8,12,18,24,38,52 weeks)