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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-25 and Atorvastatin | Experimental | HS-25 20mg, Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet |
|
| Atorvastatin | Active Comparator | Atorvastatin 20mg, Placebo of HS-25 2 tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-25 and Atorvastatin | Drug | HS-25 20mg (2 tablets), Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet oral, once daily |
|
| 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 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Litong Qi | Peking University First Hospital | Principal Investigator |
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Double blind, Double dummy
| Atorvastatin | Drug | Atorvastatin 20mg (2 tablets), Placebo of HS-25 2 tablets, oral, once daily |
|
| 2,4,8,12 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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