NCT05970679

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Daewon Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-08-17
• Primary completion: 2023-04-13
• Completion: 2023-04-13
• First posted: 2023-08-01
• Last updated: 2023-08-01

Locations

1 site across 1 country: South Korea