Efficacy and Safety of HS-25 or in Combination With Atorvastatin in Chinese Adults With Primary Hypercholesterolemia
- Conditions
- Primary Hypercholesterolemia
- Interventions
- Registration Number
- NCT03464682
- Lead Sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 720
- Subjects who are 18 to 70 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 3.36mmol/L (130 mg/dL) to 4.88 mmol/L (189 mg/dL) (inclusive) on a cholesterol lowering diet but no lipid modifying drug treatment (statins) for at least 6 weeks before signed written informed consent;
- 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 3.36mmol/L (130 mg/dL) to 4.88 mmol/L (189 mg/dL) (inclusive) for inclusion in the study.
- 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 Aorvastatin 10mg Atorvastatin 10mg Aorvastatin 10mg, Placebo of HS-25 2 tablets, oral once daily, 12 weeks HS-25 20mg combination with Atorvastatin HS-25 20mg combination with Atorvastatin HS-25 20mg, Aorvastatin 10mg, oral once daily, 12 weeks HS-25 20mg HS-25 20mg HS-25 10mg 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks HS-25 10mg HS-25 10mg HS-25 10mg, Placebo of HS-25 1 tablet, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks HS-25 10mg Placebe of HS-25 and Atorvastatin HS-25 10mg, Placebo of HS-25 1 tablet, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks HS-25 10mg combination with Atorvastatin Atorvastatin 10mg HS-25 10mg, Aorvastatin 10mg, Placebo of HS-25 1 tablet, oral once daily, 12 weeks HS-25 20mg Placebe of HS-25 and Atorvastatin HS-25 10mg 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks HS-25 20mg combination with Atorvastatin Atorvastatin 10mg HS-25 20mg, Aorvastatin 10mg, oral once daily, 12 weeks Placebo of HS-25 and Aorvastatin Placebe of HS-25 and Atorvastatin Placebo of HS-25 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12 weeks HS-25 10mg combination with Atorvastatin HS-25 10mg combination with Atorvastatin HS-25 10mg, Aorvastatin 10mg, Placebo of HS-25 1 tablet, oral once daily, 12 weeks HS-25 10mg combination with Atorvastatin Placebe of HS-25 and Atorvastatin HS-25 10mg, Aorvastatin 10mg, Placebo of HS-25 1 tablet, oral once daily, 12 weeks Aorvastatin 10mg Placebe of HS-25 and Atorvastatin Aorvastatin 10mg, Placebo of HS-25 2 tablets, oral once daily, 12 weeks
- Primary Outcome Measures
Name Time Method Percent change of LDL-C 12 weeks Percent change in LDL-C from baseline to week 12 for each group
- Secondary Outcome Measures
Name Time Method Percent change of LDL-C 52 weeks ( including 2, 4, 8, 18, 24, 38, 52 weeks) Percent change in LDL-C from baseline to week 2, 4, 8, 18, 24, 38, 52 for each group
Percent change of Non-HDL-C 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks) Percent change in Non-HDL-C from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group
Percent change of HDL-C 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks) Percent change in HDL-C from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group
Percent change of TC, TG, Apo B, Apo Al 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks) Percent change in TC, TG, Apo B, Apo Al from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group