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

Daewon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia, Dyslipidemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05970679

DW1125-301

Details and patient eligibility

About

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

Enrollment: 252 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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252 participants in 4 patient groups, including a placebo group

DW1125

Experimental group

Description:

1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily

Treatment:

Drug: Ezetimibe/Atorvastatin 10/5 mg

Drug: DW1125A-1 placebo

Drug: DW1125E placebo

Drug: DW1125A placebo

DW1125A

Experimental group

Description:

1 Atorvastatin 5 mg tablet orally once daily

Treatment:

Drug: DW1125A-1 placebo

Drug: DW1125E placebo

Drug: Atorvastatin 5mg

Drug: DW1125 placebo

DW1125E

Placebo Comparator group

Description:

1 Ezetimibe 10mg tablet orally once daily

Treatment:

Drug: DW1125A-1 placebo

Drug: Ezetimibe 10mg

Drug: DW1125A placebo

Drug: DW1125 placebo

DW1125A-1

Placebo Comparator group

Description:

1 Atorvastatin 10mg tablet orally once daily

Treatment:

Drug: DW1125E placebo

Drug: Atorvastatin 10mg

Drug: DW1125A placebo

Drug: DW1125 placebo