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

Phase 3

Completed

• Conditions: Hypercholesterolemia in Coronaory Heart Disease
• Interventions: Drug: HS-25 and Atorvastatin; Drug: Atorvastatin

• Registration Number: NCT03433196
• Lead Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-07
• Status Verified: 2018-02
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-14
• Primary Completion: 2018-06-30
• Study Completion: 2018-10-10
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HS-25 and Atorvastatin	HS-25 and Atorvastatin	HS-25 20mg, Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet
Atorvastatin	Atorvastatin	Atorvastatin 20mg, Placebo of HS-25 2 tablets

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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