NCT03413462

Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 374 (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 adults with primary hypercholesterolemia; To determine the safety of HS-25 (20mg) in subjects with LDL-C

Detailed description

This is a 12-week, randomized, double-blind, placebo-controlled study designed to assess the effects of the cholesterol absorption inhibitor HS-25 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 18-75 years old men or women who are using a highly effective birth control method or are not of childbearing potential. Patients with diabetes, a history of myocardial infarction or other clinical evidence of atherosclerotic vascular disease are not eligible for participation in the study.

Conditions

• Primary Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	HS-25	HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks.
DRUG	Placebo of HS-25	Placebo HS-25 10mg/tablet, 20mg,once daily,for 12 weeks,and then HS-25 20mg once daily for 40 weeks.

Timeline

• Start date: 2016-04-12
• Primary completion: 2018-04-20
• Completion: 2018-09-20
• First posted: 2018-01-29
• Last updated: 2018-10-18