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

Phase 3

Completed

• Conditions: Hypercholesterolemia, Dyslipidemia
• Interventions: Drug: Ezetimibe 10mg; Drug: Atorvastatin 10mg; Drug: Ezetimibe/Atorvastatin 10/5 mg; Drug: Atorvastatin 5mg; Drug: DW1125 placebo; Drug: DW1125E placebo; Drug: DW1125A placebo; Drug: DW1125A-1 placebo

• Registration Number: NCT05970679
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-17
• Primary Completion: 2023-04-13
• Study Completion: 2023-04-13
• Status Verified: 2023-07
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Last Update Submitted: 2023-07-24
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• Both gender, the person aged 19 or older
• Patients who are diagnosed with primary Hypercholesterolemia or Mixed Dyslipidemia
• LDL- C ≤ 250 mg/dL and TG < 500 mg/dL on fasting status

Exclusion Criteria

• Patients with Myopathy, Rhabdomyolysis, Fibromyalgia, hereditary neuromuscular disorders or family history, or Creatine kinase(CK) ≥ 2 x Upper Limit of Normal(ULN) on Visit 1
• Patients with severe renal disorders, Estimated Flomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2 on Visit 1
• Patients with hepatic failure or active or chronic hepatobiliary diseases or aspartate transaminase (AST) or alanine aminotransferase (ALT) ≥ 2.0 x ULN on visit 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DW1125E	Ezetimibe 10mg	1 Ezetimibe 10mg tablet orally once daily
DW1125A-1	Atorvastatin 10mg	1 Atorvastatin 10mg tablet orally once daily
DW1125E	DW1125 placebo	1 Ezetimibe 10mg tablet orally once daily
DW1125	DW1125A-1 placebo	1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily
DW1125	Ezetimibe/Atorvastatin 10/5 mg	1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily
DW1125	DW1125E placebo	1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily
DW1125A	DW1125E placebo	1 Atorvastatin 5 mg tablet orally once daily
DW1125A-1	DW1125A placebo	1 Atorvastatin 10mg tablet orally once daily
DW1125A-1	DW1125E placebo	1 Atorvastatin 10mg tablet orally once daily
DW1125	DW1125A placebo	1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily
DW1125A	Atorvastatin 5mg	1 Atorvastatin 5 mg tablet orally once daily
DW1125A	DW1125 placebo	1 Atorvastatin 5 mg tablet orally once daily
DW1125A	DW1125A-1 placebo	1 Atorvastatin 5 mg tablet orally once daily
DW1125E	DW1125A placebo	1 Ezetimibe 10mg tablet orally once daily
DW1125A-1	DW1125 placebo	1 Atorvastatin 10mg tablet orally once daily
DW1125E	DW1125A-1 placebo	1 Ezetimibe 10mg tablet orally once daily

Primary Outcome Measures

Name	Time	Method
% Change of LDL-C	8 weeks	% Change of LDL-C in week 8 from baseline

Secondary Outcome Measures

Name	Time	Method
% Change of LDL-C	4 weeks	% Change of LDL-C in week 4 from baseline
% Change of Lipid parameters	4 weeks and 8 weeks	% Change of Lipid parameters(TC, TG, HDL-C, Non-HDL-C, Apo A1, Apo B) in week 4 and week 8 respectively after administrating the treatment drugs
LDL-C goal achievement rates	4 weeks and 8 weeks	LDL-C goal achievement rates in week 4 and week 8 respectively after administrating the treatment drugs (goal achievement for LDL-C: low risk group: \< 160 mg/dL, intermediate risk group: \<130 mg/dL, high risk group: \< 100 mg/dL, extreme risk group: \< 70 mg/dL)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of