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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-25 10mg | Experimental | HS-25 10mg, Placebo of HS-25 1 tablet, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks |
|
| HS-25 20mg | Experimental | HS-25 10mg 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks |
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| HS-25 10mg combination with Atorvastatin | Experimental | HS-25 10mg, Aorvastatin 10mg, Placebo of HS-25 1 tablet, oral once daily, 12 weeks |
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| HS-25 20mg combination with Atorvastatin | Experimental | HS-25 20mg, Aorvastatin 10mg, oral once daily, 12 weeks |
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| Aorvastatin 10mg | Active Comparator | Aorvastatin 10mg, Placebo of HS-25 2 tablets, oral once daily, 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-25 10mg | Drug | HS-25 10mg 1tablet add placebo of HS-25 1 tablet, placebo of Atorvastatin 1 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change of LDL-C | Percent change in LDL-C from baseline to week 12 for each group | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change of LDL-C | Percent change in LDL-C from baseline to week 2, 4, 8, 18, 24, 38, 52 for each group | 52 weeks ( including 2, 4, 8, 18, 24, 38, 52 weeks) |
| Percent change of Non-HDL-C | Percent change in Non-HDL-C from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianan Wang | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
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| Placebo of HS-25 and Aorvastatin | Placebo Comparator | Placebo of HS-25 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12 weeks |
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| HS-25 10mg combination with Atorvastatin | Drug | HS-25 10mg 1 tablet , Atorvastatin 10mg 1 tablet, Placebo of HS-25 1 tablet |
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| HS-25 20mg combination with Atorvastatin | Drug | HS-25 10mg 2 tablets, Atorvastatin 10mg 1 tablet |
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| Atorvastatin 10mg | Drug | Atorvastatin 10mg 1 tablet, placebo of HS-25 2 tablets |
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| HS-25 20mg | Drug | HS-25 10mg 2 tablets, placebo of Atorvastatin 1 tablet |
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| Placebe of HS-25 and Atorvastatin | Drug | Placebe of HS-25 2 tablets, Placebo of Atorvastatin 1 tablets |
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| 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks) |
| Percent change of HDL-C | Percent change in HDL-C from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group | 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks) |
| Percent change of TC, TG, Apo B, Apo Al | Percent change in TC, TG, Apo B, Apo Al from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group | 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks) |
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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