Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia

NCT ID: NCT03413462

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 374 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-12
• Study Completion Date: 2018-09-20

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.

Conditions

Primary Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

HS-25

20mg, QD, 12 weeks

Group Type: ACTIVE_COMPARATOR

HS-25

Intervention Type: DRUG

HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks.

Placebo of HS-25

20mg, QD, 12 weeks

Group Type: PLACEBO_COMPARATOR

HS-25

Intervention Type: DRUG

HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks.

Placebo of HS-25

Intervention Type: DRUG

Placebo HS-25 10mg/tablet, 20mg,once daily,for 12 weeks,and then HS-25 20mg once daily for 40 weeks.

Interventions

HS-25

HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks.

Intervention Type: DRUG

Placebo of HS-25

Placebo HS-25 10mg/tablet, 20mg,once daily,for 12 weeks,and then HS-25 20mg once daily for 40 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Hisun Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yong Huo

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Other Identifiers

HS-25-III-01

Identifier Type: -

Identifier Source: org_study_id