NCT03433196

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypercholesterolemia in Coronaory Heart Disease

Interventions

Type	Name	Description
DRUG	HS-25 and Atorvastatin	HS-25 20mg (2 tablets), Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet oral, once daily
DRUG	Atorvastatin	Atorvastatin 20mg (2 tablets), Placebo of HS-25 2 tablets, oral, once daily

Timeline

• Start date: 2016-06-07
• Primary completion: 2018-06-30
• Completion: 2018-10-10
• First posted: 2018-02-14
• Last updated: 2018-10-18