Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia
- Conditions
- Primary Hypercholesterolemia
- Interventions
- Drug: Placebo of HS-25
- Registration Number
- NCT03413462
- Lead Sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 374
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HS-25 HS-25 20mg, QD, 12 weeks Placebo of HS-25 HS-25 20mg, QD, 12 weeks Placebo of HS-25 Placebo of HS-25 20mg, QD, 12 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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