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Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A

NCT05970679 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2023-08-01

No results posted yet for this study

Summary

A Randomized, Double blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient with primary Hypercholesterolemia or Mixed Dyslipidemia

Conditions

  • Hypercholesterolemia, Dyslipidemia

Interventions

DRUG

Ezetimibe/Atorvastatin 10/5 mg

DW1125

DRUG

Atorvastatin 5mg

DW1125A

DRUG

Ezetimibe 10mg

DW1125E

DRUG

Atorvastatin 10mg

DW1125A-1

DRUG

DW1125 placebo

Ezetimibe/Atorvastatin 10/5 mg placebo

DRUG

DW1125A placebo

Atorvastatin 5mg placebo

DRUG

DW1125E placebo

Ezetimibe 10mg placebo

DRUG

DW1125A-1 placebo

Atorvastatin 10mg placebo

Sponsors & Collaborators

  • Daewon Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kim · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2023-04-13
Completion
2023-04-13

Countries

  • South Korea

Study Locations

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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 NCT05970679 on ClinicalTrials.gov