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

Hypercholesterolemia in Coronaory Heart Disease Clinical Trial

— HS-25-III-02  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433196
• Other study ID #: HS-25-III-02
• Status: Completed
• Phase: Phase 3
• Start date: June 7, 2016
• Est. completion date: October 10, 2018

Study information

• Verified date: February 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: October 10, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hypercholesterolemia
• Hypercholesterolemia in Coronaory Heart Disease
• Myocardial Ischemia

Intervention

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

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