Multi-center,Randomized,Double Blind, Double Dummy,Placebo Controlled, Efficacy and Safety Study of HS-25 in Combination With Atovastatin in Adults With Primary Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 720
- 主要终点
- Percent change of LDL-C
研究概览
简要总结
To determine the efficacy of the HS-25 (10mg or 20mg) or in combination with Atorvastatin (10mg)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 (10mg or 20mg) or in combination with Atorvastatin (10mg)in subjects with LDL-C after a 40-week period of treament.
详细描述
This is a 12-week, randomized, double-blind, double dummy, placebo-controlled study designed to assess the effects of the cholesterol absorption inhibitor HS-25 (10mg or 20mg) or in combination with Atorvastatin (10mg) 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 18-70 years old men or women who are using a highly effective birth control method or are not of childbearing potential;subjects with not treated by statins in six months before signature of the informed consent.Subjects with diabetes, a history of myocardial infarction or other clinical evidence of atherosclerotic vascular disease or treated 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are 18 to 70 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 3.36mmol/L (130 mg/dL) to 4.88 mmol/L (189 mg/dL) (inclusive) on a cholesterol lowering diet but no lipid modifying drug treatment (statins) for at least 6 weeks before signed written informed consent;
- •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 3.36mmol/L (130 mg/dL) to 4.88 mmol/L (189 mg/dL) (inclusive) for inclusion in the study.
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 10mg
HS-25 10mg, Placebo of HS-25 1 tablet, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks
干预措施: HS-25 10mg (Drug)
HS-25 10mg
HS-25 10mg, Placebo of HS-25 1 tablet, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks
干预措施: Placebe of HS-25 and Atorvastatin (Drug)
HS-25 20mg
HS-25 10mg 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks
干预措施: HS-25 20mg (Drug)
HS-25 20mg
HS-25 10mg 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks
干预措施: Placebe of HS-25 and Atorvastatin (Drug)
HS-25 10mg combination with Atorvastatin
HS-25 10mg, Aorvastatin 10mg, Placebo of HS-25 1 tablet, oral once daily, 12 weeks
干预措施: HS-25 10mg combination with Atorvastatin (Drug)
HS-25 10mg combination with Atorvastatin
HS-25 10mg, Aorvastatin 10mg, Placebo of HS-25 1 tablet, oral once daily, 12 weeks
干预措施: Atorvastatin 10mg (Drug)
HS-25 10mg combination with Atorvastatin
HS-25 10mg, Aorvastatin 10mg, Placebo of HS-25 1 tablet, oral once daily, 12 weeks
干预措施: Placebe of HS-25 and Atorvastatin (Drug)
HS-25 20mg combination with Atorvastatin
HS-25 20mg, Aorvastatin 10mg, oral once daily, 12 weeks
干预措施: HS-25 20mg combination with Atorvastatin (Drug)
HS-25 20mg combination with Atorvastatin
HS-25 20mg, Aorvastatin 10mg, oral once daily, 12 weeks
干预措施: Atorvastatin 10mg (Drug)
Aorvastatin 10mg
Aorvastatin 10mg, Placebo of HS-25 2 tablets, oral once daily, 12 weeks
干预措施: Atorvastatin 10mg (Drug)
Aorvastatin 10mg
Aorvastatin 10mg, Placebo of HS-25 2 tablets, oral once daily, 12 weeks
干预措施: Placebe of HS-25 and Atorvastatin (Drug)
Placebo of HS-25 and Aorvastatin
Placebo of HS-25 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12 weeks
干预措施: Placebe of HS-25 and Atorvastatin (Drug)
结局指标
主要结局
Percent change of LDL-C
时间窗: 12 weeks
Percent change in LDL-C from baseline to week 12 for each group
次要结局
- Percent change of LDL-C(52 weeks ( including 2, 4, 8, 18, 24, 38, 52 weeks))
- Percent change of Non-HDL-C(52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks))
- Percent change of HDL-C(52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks))
- Percent change of TC, TG, Apo B, Apo Al(52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks))