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

NCT03413462 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2018-10-18

No results posted yet for this study

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

Conditions

  • Primary Hypercholesterolemia

Interventions

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.

Sponsors & Collaborators

  • Zhejiang Hisun Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Yong Huo · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-12
Primary Completion
2018-04-20
Completion
2018-09-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03413462 on ClinicalTrials.gov