NCT07444762

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Daewon Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective is to demonstrate the superiority of combination therapy of DW5421A/DW5421B over monotherapy of DW5421A by comparing the change in LDL-C at week 8 after administration. Approximately equal numbers of patients were randomized in a 1:1 ratio to receive combination therapy of DW5421A/DW5421B or monotherapy of DW5421A for 8 weeks. Efficacy and safety assessments were conducted at week 4 and week 8.

Conditions

• Primary Hypercholesterolemia
• Mixed Dyslipidemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-21
• Primary completion: 2025-10-21
• Completion: 2025-10-21
• First posted: 2026-03-03
• Last updated: 2026-03-06

Locations

1 site across 1 country: South Korea