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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)

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ClinicalTrials.gov Identifier: NCT03433196
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia in Coronaory Heart Disease Drug: HS-25 and Atorvastatin Drug: Atorvastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind, Double dummy
Primary Purpose: Treatment
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
Actual Study Start Date : June 7, 2016
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : October 10, 2018


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




Primary Outcome Measures :
  1. Percent change of LDL-C [ Time Frame: 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 :
  1. Percent change of Non-HDL-C [ Time Frame: 2,4,8,12 weeks ]
    Percent change from baseline in Non-HDL-C after 2,4,8,12 weeks of double-blind treatment

  2. Percent change of TC,TG,ApoB,ApoAI [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433196


Sponsors and Collaborators
Zhejiang Hisun Pharmaceutical Co. Ltd.
Investigators
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Principal Investigator: Litong Qi Peking University First Hospital

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Responsible Party: Zhejiang Hisun Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT03433196     History of Changes
Other Study ID Numbers: HS-25-III-02
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Hypercholesterolemia
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors