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

Primary Hypercholesterolemia Clinical Trial

— HS-25-III-01  

Official title:

Multi-center,Randomized,Double Blind,Placebo Controlled,Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413462
• Other study ID #: HS-25-III-01
• Status: Completed
• Phase: Phase 3
• Start date: April 12, 2016
• Est. completion date: September 20, 2018

Study information

• Verified date: January 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 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

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 information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: September 20, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

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

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	LDL-C	Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment	2,4,8,12,18,24,38,52 weeks
Secondary	Non-HDL-C	Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment	2,4,8,12,18,24,38,52 weeks
Secondary	HDL-C	Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment	2,4,8,12,18,24,38,52 weeks
Secondary	TC	Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment	2,4,8,12,18,24,38,52 weeks
Secondary	TG	Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment	2,4,8,12,18,24,38,52 weeks