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

Hypercholesterolemia, Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05970679
• Other study ID #: DW1125-301
• Status: Completed
• Phase: Phase 3
• Start date: August 17, 2022
• Est. completion date: April 13, 2023

Study information

• Verified date: July 2023
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: April 13, 2023
• Est. primary completion date: April 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Hypercholesterolemia, Dyslipidemia

Intervention

Drug:
• Ezetimibe/Atorvastatin 10/5 mg
DW1125
• Atorvastatin 5mg
DW1125A
• Ezetimibe 10mg
DW1125E
• Atorvastatin 10mg
DW1125A-1
• DW1125 placebo
Ezetimibe/Atorvastatin 10/5 mg placebo
• DW1125A placebo
Atorvastatin 5mg placebo
• DW1125E placebo
Ezetimibe 10mg placebo
• DW1125A-1 placebo
Atorvastatin 10mg placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Change of LDL-C	% Change of LDL-C in week 8 from baseline	8 weeks
Secondary	% Change of LDL-C	% Change of LDL-C in week 4 from baseline	4 weeks
Secondary	% Change of Lipid parameters	% 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	4 weeks and 8 weeks
Secondary	LDL-C goal achievement rates	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)	4 weeks and 8 weeks