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

Hisun Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia in Coronaory Heart Disease

Treatments: Drug: Atorvastatin; Drug: HS-25 and Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03433196

HS-25-III-02

Details and patient eligibility

About

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

Enrollment: 255 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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255 participants in 2 patient groups

HS-25 and Atorvastatin

Experimental group

Description:

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

Treatment:

Drug: HS-25 and Atorvastatin

Atorvastatin

Active Comparator group

Description:

Atorvastatin 20mg, Placebo of HS-25 2 tablets

Treatment:

Drug: Atorvastatin