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Safety and Efficacy of CVI-LM001 in Patients With Hypercholesterolemia

NCT04438096 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-06-23

No results posted yet for this study

Summary

The purpose of this study is to determine if CVI-LM001 is effective and safe versus placebo in drug-naive subjects with elevated LDL cholesterol. There will be 4 groups receiving 100mg, 200mg, 300 mg and placebo treatment for 12 weeks respectively.

Conditions

Interventions

DRUG

100 mg

One 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks

DRUG

200 mg

Two 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks

DRUG

300 mg

Three 100 mg pills (QD) will be orally administered for 12 weeks

DRUG

Placebo

Three placebo pills (QD) will be orally administered for 12 weeks

Sponsors & Collaborators

  • CVI Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Que Liu, MDPhD · CVI Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2021-12-15
Completion
2022-03-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04438096 on ClinicalTrials.gov