NCT03433196已完成3 期
Randomized,Double Blind,Double Dummy, Multi-center Study of Efficacy and Safety of HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases
Zhejiang Hisun Pharmaceutical Co. Ltd.0 个研究点目标入组 255 人开始时间: 2016年6月7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
- 255
- 主要终点
- Percent change of 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 combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases; To determine the safety of HS-25 (20mg) combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases
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)
盲法说明
Double blind, Double dummy
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
- •Diet control for 14 weeks, Atorvastatin 10mg once daily for 6 weeks or above;
- •The average of both qualifying values must be in the range of 2.07 mmol/L to 3.36 mmol/L. 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;
- •Must meet the one of diseases as following:
- •Subjects who have stable coronary heart disease;
- •Subjects who diagnosed ischemic stroke in stable condition;
- •Subjects who diagnosed as Diabetes mellitus
排除标准
- •history of Severe Endiocrine disease (for example Thyroid function abnormal);
- •History of advanced cancer
- •Arrhythmias need to be treated by medications history of Hemorrhagic stroke;
- •Cardiac dysfunction;
- •Unstable ASCVD;
- •History of organ transplant;
- •Hypersensitive to HS-25 or place;
- •uncontrolled or new diagnosed diabetes mellitus;
- •HCV and HBsAg positive
研究组 & 干预措施
HS-25 and Atorvastatin
Experimental
HS-25 20mg, Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet
干预措施: HS-25 and Atorvastatin (Drug)
Atorvastatin
Active Comparator
Atorvastatin 20mg, Placebo of HS-25 2 tablets
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Percent change of LDL-C
时间窗: 2,4,8,12 weeks
Percent change from baseline in LDL-C after 2,4,8,12 weeks of double-blind treatment
次要结局
- Percent change of Non-HDL-C(2,4,8,12 weeks)
- Percent change of TC,TG,ApoB,ApoAI(2,4,8,12 weeks)
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