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

NCT ID: NCT03433196

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-07
• Study Completion Date: 2018-10-10

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

Conditions

Hypercholesterolemia in Coronaory Heart Disease

Study Design

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

Study Groups

HS-25 and Atorvastatin

HS-25 20mg, Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet

Group Type: EXPERIMENTAL

HS-25 and Atorvastatin

Intervention Type: DRUG

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

Atorvastatin

Atorvastatin 20mg, Placebo of HS-25 2 tablets

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

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

Interventions

HS-25 and Atorvastatin

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

Intervention Type: DRUG

Atorvastatin

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

Intervention Type: DRUG

Eligibility Criteria

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

• 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

Litong Qi

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Other Identifiers

HS-25-III-02

Identifier Type: -

Identifier Source: org_study_id