drugset / Trial / NCT03464682

Efficacy and Safety of HS-25 or in Combination With Atorvastatin in Chinese Adults With Primary Hypercholesterolemia

NCT03464682

Phase 3 Unknown 720 enrolled Zhejiang Hisun Pharmaceutical Co. Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

To determine the efficacy of the HS-25 (10mg or 20mg) or in combination with Atorvastatin (10mg)in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period of treatment in adults with primary hypercholesterolemia; To determine the safety of HS-25 (10mg or 20mg) or in combination with Atorvastatin (10mg)in subjects with LDL-C after a 40-week period of treament.

Timeline

Start
2015-02-28
Primary completion
2018-12-28
Completion
2019-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 10 mg Oral
Subject HYZETIMIBE Small molecule 10 mg Oral
Subject HYZETIMIBE Small molecule 20 mg Oral

Indications