Primary Hypercholesterolemia
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGHS-25
HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks.
DRUGPlacebo of HS-25
Placebo HS-25 10mg/tablet, 20mg,once daily,for 12 weeks,and then HS-25 20mg once daily for 40 weeks.
Sponsors
Zhejiang Hisun Pharmaceutical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who are 18 to 75 years of age, male or female using a highly effective birth control method or not of child-bearing potential, at Visit 1 (screening visit). * LDL-C 130 to 189 mg/dL (inclusive) on a cholesterol lowering diet but no lipid modifying drug treatment for at least 6 weeks. * A qualifying LDL-C value must be obtained at the beginning and end of the placebo 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; the average of both qualifying values must be in the range of 130 to 189 mg/dL (inclusive) for inclusion in the study. * TG ≤ 350 mg/dL on a cholesterol lowering diet but no lipid modifying drug treatment for at least 6 weeks and TG levels must be ≤ 350 mg/dL at both Visit 2 and Visit 3 * Signed written informed consent.
Exclusion criteria
* Liver transaminases \> 1.5 x upper limit of normal. * Homozygous Familial Hypercholesterolemia. * Subject who was diagnosed as diabetes with aged greater than 40 years old. * Subject who was diagnosed as diabetes with one of the following of cardiovascular risk factorss: Hypertention Bp ≥ 140/90mmHg,or smoking, or low HDL-C (1.04mmol/L), or BMI≥28kg/m2. * Women who are pregnant or breast feeding. * Atherosclerotic cardiovascular disease including Arteriosclerotic heart disease, Acute coronary syndrome，Coronary artery bypass graft,Coronary angioplastyPeripheral arteriosclerosis,Cerebrovascular accident * history of Severe Endiocrine disease (for example Thyroid function abnormal) * History of a positive test for human immunodeficiency virus, hepatitis B or hepatitis C. * History of advanced cancer * Arrhythmias need to be treated by medications * Had severe injured or surgery in 6 months before study start. * Hypersensitive to HS-25 or place. * History of intolerance to ezetimibe. * Participation other studies in three months. * Treatment with a fibric acid derivative (eg, fenofibrate, gemfibrozil), probucol, warfarin, systemic corticosteroid, cyclosporine or other immunosuppressant agent within the prior 12 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C | 2,4,8,12,18,24,38,52 weeks | Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-HDL-C | 2,4,8,12,18,24,38,52 weeks | Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment |
| HDL-C | 2,4,8,12,18,24,38,52 weeks | Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment |
| TC | 2,4,8,12,18,24,38,52 weeks | Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment |
| TG | 2,4,8,12,18,24,38,52 weeks | Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment |
Outcome results
None listed