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

• Status: Completed
• Trial end date: 2018-10-10
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Treatments: Atorvastatin; Atorvastatin Calcium

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