Efficacy and Safety of HS-25 or in Combination With Atorvastatin in Chinese Adults With Primary Hypercholesterolemia

Primary Hypercholesterolemia Clinical Trial

— HS-25-C-01  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03464682
• Other study ID #: HS-25-C-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 28, 2015
• Est. completion date: May 28, 2019

Study information

• Verified date: February 2018
• Source: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 720
• Est. completion date: May 28, 2019
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

Drug:
• HS-25 10mg
HS-25 10mg 1tablet add placebo of HS-25 1 tablet, placebo of Atorvastatin 1 tablet
• HS-25 10mg combination with Atorvastatin
HS-25 10mg 1 tablet , Atorvastatin 10mg 1 tablet, Placebo of HS-25 1 tablet
• HS-25 20mg combination with Atorvastatin
HS-25 10mg 2 tablets, Atorvastatin 10mg 1 tablet
• Atorvastatin 10mg
Atorvastatin 10mg 1 tablet, placebo of HS-25 2 tablets
• HS-25 20mg
HS-25 10mg 2 tablets, placebo of Atorvastatin 1 tablet
• Placebe of HS-25 and Atorvastatin
Placebe of HS-25 2 tablets, Placebo of Atorvastatin 1 tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Hisun Pharmaceutical Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change of LDL-C	Percent change in LDL-C from baseline to week 12 for each group	12 weeks
Secondary	Percent change of LDL-C	Percent change in LDL-C from baseline to week 2, 4, 8, 18, 24, 38, 52 for each group	52 weeks ( including 2, 4, 8, 18, 24, 38, 52 weeks)
Secondary	Percent change of Non-HDL-C	Percent change in Non-HDL-C from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group	52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)
Secondary	Percent change of HDL-C	Percent change in HDL-C from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group	52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)
Secondary	Percent change of TC, TG, Apo B, Apo Al	Percent change in TC, TG, Apo B, Apo Al from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group	52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)