Efficacy and Safety Study of the HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases

Randomized,Double Blind,Double Dummy, Multi-center Study of Efficacy and Safety of HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03433196

Acronym

HS-25-III-02

Enrollment

255

Registered

2018-02-14

Start date

2016-06-07

Completion date

2018-10-10

Last updated

2018-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia in Coronaory Heart Disease

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 combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases; To determine the safety of HS-25 (20mg) combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases

Interventions

DRUGHS-25 and Atorvastatin

HS-25 20mg (2 tablets), Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet oral, once daily

DRUGAtorvastatin

Atorvastatin 20mg (2 tablets), Placebo of HS-25 2 tablets, oral, once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double blind, Double dummy

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Diet control for 14 weeks, Atorvastatin 10mg once daily for 6 weeks or above; * The average of both qualifying values must be in the range of 2.07 mmol/L to 3.36 mmol/L. 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; * Must meet the one of diseases as following: 1. Subjects who have stable coronary heart disease; 2. Subjects who diagnosed ischemic stroke in stable condition; 3. Subjects who diagnosed as Diabetes mellitus

Exclusion criteria

* history of Severe Endiocrine disease (for example Thyroid function abnormal); * History of advanced cancer * Arrhythmias need to be treated by medications history of Hemorrhagic stroke; * Cardiac dysfunction; * Unstable ASCVD; * History of organ transplant; * Hypersensitive to HS-25 or place; * uncontrolled or new diagnosed diabetes mellitus; * HCV and HBsAg positive

Design outcomes

Primary

Measure	Time frame	Description
Percent change of LDL-C	2,4,8,12 weeks	Percent change from baseline in LDL-C after 2,4,8,12 weeks of double-blind treatment

Secondary

Measure	Time frame	Description
Percent change of Non-HDL-C	2,4,8,12 weeks	Percent change from baseline in Non-HDL-C after 2,4,8,12 weeks of double-blind treatment
Percent change of TC,TG,ApoB,ApoAI	2,4,8,12 weeks	Percent change from baseline in TC,TG,ApoB and ApoAI after 2,4,8,12 weeks of double-blind treat

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026