Efficacy and Safety Study of the HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases (HS-25-III-02)

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

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

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia in Coronaory Heart Disease
• Intervention / Treatment: Drug: HS-25 and Atorvastatin; Drug: Atorvastatin

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-25 and Atorvastatin; HS-25 20mg, Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet	Drug: HS-25 and Atorvastatin; HS-25 20mg (2 tablets), Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet oral, once daily
Active Comparator: Atorvastatin; Atorvastatin 20mg, Placebo of HS-25 2 tablets	Drug: Atorvastatin; Atorvastatin 20mg (2 tablets), Placebo of HS-25 2 tablets, oral, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Litong Qi, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): October 10, 2018

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: HS-25-III-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No