NCT03464682

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

Multi-center,Randomized,Double Blind, Double Dummy,Placebo Controlled, Efficacy and Safety Study of HS-25 in Combination With Atovastatin in Adults With Primary Hypercholesterolemia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a 12-week, randomized, double-blind, double dummy, placebo-controlled study designed to assess the effects of the cholesterol absorption inhibitor HS-25 (10mg or 20mg) or in combination with Atorvastatin (10mg) on LDL-C levels in adults who have untreated LDL-C levels ranging from 3.36-4.88mmol/L(130-189 mg/dL)and fasting triglyceride levels \< 350 mg/dL. Eligibility is restricted to 18-70 years old men or women who are using a highly effective birth control method or are not of childbearing potential;subjects with not treated by statins in six months before signature of the informed consent.Subjects with diabetes, a history of myocardial infarction or other clinical evidence of atherosclerotic vascular disease or treated are not eligible for participation in the study.

Conditions

• Primary Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	HS-25 10mg	HS-25 10mg 1tablet add placebo of HS-25 1 tablet, placebo of Atorvastatin 1 tablet
DRUG	HS-25 10mg combination with Atorvastatin	HS-25 10mg 1 tablet , Atorvastatin 10mg 1 tablet, Placebo of HS-25 1 tablet
DRUG	HS-25 20mg combination with Atorvastatin	HS-25 10mg 2 tablets, Atorvastatin 10mg 1 tablet
DRUG	Atorvastatin 10mg	Atorvastatin 10mg 1 tablet, placebo of HS-25 2 tablets
DRUG	HS-25 20mg	HS-25 10mg 2 tablets, placebo of Atorvastatin 1 tablet
DRUG	Placebe of HS-25 and Atorvastatin	Placebe of HS-25 2 tablets, Placebo of Atorvastatin 1 tablets

Timeline

• Start date: 2015-02-28
• Primary completion: 2018-12-28
• Completion: 2019-05-28
• First posted: 2018-03-14
• Last updated: 2018-10-18