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

NCT03464682 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2018-10-18

No results posted yet for this study

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.

Conditions

  • Primary Hypercholesterolemia

Interventions

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

Sponsors & Collaborators

  • Zhejiang Hisun Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Jianan Wang · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

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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 NCT03464682 on ClinicalTrials.gov