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Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of DW5421A/DW5421B Compared to Monotherapy of DW5421A

NCT07444762 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2026-03-06

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, active-controlled, parallel, phase III clinical trial to evaluate the efficacy and safety of combination therapy of DW5421A/DW5421B versus monotherapy of DW5421A in patients with primary hypercholesterolemia or mixed dyslipidemia.

Conditions

  • Primary Hypercholesterolemia
  • Mixed Dyslipidemia

Interventions

DRUG

DW5421A

IP is administered orally once daily at a consistent time each day, with or without food.

DRUG

DW5421B Placebo

IP is administered orally once daily at a consistent time each day, with or without food.

DRUG

DW5421B

IP is administered orally once daily at a consistent time each day, with or without food.

Sponsors & Collaborators

  • Daewon Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-21
Primary Completion
2025-10-21
Completion
2025-10-21

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 NCT07444762 on ClinicalTrials.gov