Loading clinical trials...

Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT03413462•Zhejiang Hisun Pharmaceutical Co. Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Key Dates

Start Date

April 12, 2016

Primary Completion Date

April 20, 2018

Completion Date

September 20, 2018

Last Updated

October 18, 2018

Enrollment

374

ACTUAL participants

Conditions

Primary Hypercholesterolemia

Interventions

HS-25

DRUG

Placebo of HS-25

DRUG

A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib

NCT06314919

Primary HypercholesterolemiaMixed Dyslipidemia

View study

RECRUITINGPHASE3

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

NCT06568471

HypercholesterolemiaDyslipidemias+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 18, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD

QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)

QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia

An OS to Evaluate the Safety & Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe