Clinical trial NCT03464682: Efficacy and Safety of HS-25 or in Combination With Atorvastatin in Chinese Adults With Primary Hypercholesterolemia
Official title: Multi-center,Randomized,Double Blind, Double Dummy,Placebo Controlled, Efficacy and Safety Study of HS-25 in Combination With Atovastatin in Adults With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Lead sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-14
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Percent change of LDL-C
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent change of LDL-C
timeFrame: 52 weeks ( including 2, 4, 8, 18, 24, 38, 52 weeks)
measure: Percent change of Non-HDL-C
timeFrame: 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)
measure: Percent change of HDL-C
timeFrame: 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)
measure: Percent change of TC, TG, Apo B, Apo Al
timeFrame: 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jianan Wang
role: PRINCIPAL_INVESTIGATOR
References: