Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 adults with primary hypercholesterolemia;
To determine the safety of HS-25 (20mg) in subjects with LDL-C
This is a 12-week, randomized, double-blind, placebo-controlled study designed to assess the effects of the cholesterol absorption inhibitor HS-25 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 18-75 years old men or women who are using a highly effective birth control method or are not of childbearing potential. Patients with diabetes, a history of myocardial infarction or other clinical evidence of atherosclerotic vascular disease are not eligible for participation in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-25 | Active Comparator | 20mg, QD, 12 weeks |
|
| Placebo of HS-25 | Placebo Comparator | 20mg, QD, 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-25 | Drug | HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C | Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment | 2,4,8,12,18,24,38,52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Non-HDL-C | Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment | 2,4,8,12,18,24,38,52 weeks |
| HDL-C | Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yong Huo | Peking University First Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo of HS-25 | Drug | Placebo HS-25 10mg/tablet, 20mg,once daily,for 12 weeks,and then HS-25 20mg once daily for 40 weeks. |
|
| 2,4,8,12,18,24,38,52 weeks |
| TC | Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment | 2,4,8,12,18,24,38,52 weeks |
| TG | Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment | 2,4,8,12,18,24,38,52 weeks |