Efficacy and Safety Study of the HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Hypercholesterolemia in Coronaory Heart Disease

Intervention / Treatment
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* Drug: HS-25 and Atorvastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HS-25 and Atorvastatin<br>HS-25 20mg, Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet | Drug: HS-25 and Atorvastatin<br>* HS-25 20mg (2 tablets), Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet oral, once daily<br>|
| Active Comparator: Atorvastatin<br>Atorvastatin 20mg, Placebo of HS-25 2 tablets | Drug: Atorvastatin<br>* Atorvastatin 20mg (2 tablets), Placebo of HS-25 2 tablets, oral, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of LDL-C | Percent change from baseline in LDL-C after 2,4,8,12 weeks of double-blind treatment | 2,4,8,12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of Non-HDL-C | Percent change from baseline in Non-HDL-C after 2,4,8,12 weeks of double-blind treatment | 2,4,8,12 weeks | 
| Percent change of TC,TG,ApoB,ApoAI | Percent change from baseline in TC,TG,ApoB and ApoAI after 2,4,8,12 weeks of double-blind treat | 2,4,8,12 weeks |