MedTrace Logo

A 4-week, Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia

NCT02087917 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2015-01-06

No results posted yet for this study

Summary

To determine the efficacy of HS-25 (5, 10, 20 or 30 mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 4-week period of treatment in adults with primary hypercholesterolemia.

Conditions

  • Primary Hypercholesterolemia

Interventions

DRUG

HS-25

Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.

DRUG

Placebo

Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Zhejiang Hisun Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Kevin Liao, PhD · Zhejiang Hisun Pharmaceuticals Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02087917 on ClinicalTrials.gov