Status:
COMPLETED
Efficacy and Safety Study of the HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases
Lead Sponsor:
Zhejiang Hisun Pharmaceutical Co. Ltd.
Conditions:
Hypercholesterolemia in Coronaory Heart Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 hyperchol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2018
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT03433196
Start Date
June 7 2016
End Date
October 10 2018
Last Update
October 18 2018
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