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Completed

NCT Number: NCT03433196

Efficacy and Safety Study of the 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

Completed

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Key information

Conditions

Hypercholesterolemia in Coronaory Heart Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HS-25 and Atorvastatin

Drug

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

atorvastatin

Drug

Atorvastatin 20mg (2 tablets), Placebo of HS-25 2 tablets, oral, once daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

Industry

Registry information

Official study 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

Acronym: HS-25-III-02

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 14, 2018
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.