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

Primary Purpose

Hypercholesterolemia in Coronaory Heart Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
HS-25 and Atorvastatin
Atorvastatin
Sponsored by
Zhejiang Hisun Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia in Coronaory Heart Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    HS-25 and Atorvastatin

    Atorvastatin

    Arm Description

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

    Atorvastatin 20mg, Placebo of HS-25 2 tablets

    Outcomes

    Primary Outcome Measures

    Percent change of LDL-C
    Percent change from baseline in LDL-C after 2,4,8,12 weeks of double-blind treatment

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 8, 2018
    Last Updated
    October 17, 2018
    Sponsor
    Zhejiang Hisun Pharmaceutical Co. Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03433196
    Brief Title
    Efficacy and Safety Study of the HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 7, 2016 (Actual)
    Primary Completion Date
    June 30, 2018 (Actual)
    Study Completion Date
    October 10, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zhejiang Hisun Pharmaceutical Co. Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia in Coronaory Heart Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    Double blind, Double dummy
    Allocation
    Randomized
    Enrollment
    255 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HS-25 and Atorvastatin
    Arm Type
    Experimental
    Arm Description
    HS-25 20mg, Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet
    Arm Title
    Atorvastatin
    Arm Type
    Active Comparator
    Arm Description
    Atorvastatin 20mg, Placebo of HS-25 2 tablets
    Intervention Type
    Drug
    Intervention Name(s)
    HS-25 and Atorvastatin
    Intervention Description
    HS-25 20mg (2 tablets), Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet oral, once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin
    Intervention Description
    Atorvastatin 20mg (2 tablets), Placebo of HS-25 2 tablets, oral, once daily
    Primary Outcome Measure Information:
    Title
    Percent change of LDL-C
    Description
    Percent change from baseline in LDL-C after 2,4,8,12 weeks of double-blind treatment
    Time Frame
    2,4,8,12 weeks
    Secondary Outcome Measure Information:
    Title
    Percent change of Non-HDL-C
    Description
    Percent change from baseline in Non-HDL-C after 2,4,8,12 weeks of double-blind treatment
    Time Frame
    2,4,8,12 weeks
    Title
    Percent change of TC,TG,ApoB,ApoAI
    Description
    Percent change from baseline in TC,TG,ApoB and ApoAI after 2,4,8,12 weeks of double-blind treat
    Time Frame
    2,4,8,12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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: Subjects who have stable coronary heart disease; Subjects who diagnosed ischemic stroke in stable condition; 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Litong Qi
    Organizational Affiliation
    Peking University First Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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