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

Study Overview
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Brief Summary
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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

Official Title
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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
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Hypercholesterolemia, Dyslipidemia

Intervention / Treatment
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* Drug: Ezetimibe/Atorvastatin 10/5 mg
* Drug: Atorvastatin 5mg
* Drug: Ezetimibe 10mg
* Drug: Atorvastatin 10mg
* Drug: DW1125 placebo
* Drug: DW1125A placebo
* Drug: DW1125E placebo
* Drug: DW1125A-1 placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DW1125<br>1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily | Drug: Ezetimibe/Atorvastatin 10/5 mg<br>* DW1125<br>Drug: DW1125A placebo<br>* Atorvastatin 5mg placebo<br>Drug: DW1125E placebo<br>* Ezetimibe 10mg placebo<br>Drug: DW1125A-1 placebo<br>* Atorvastatin 10mg placebo<br>|
| Experimental: DW1125A<br>1 Atorvastatin 5 mg tablet orally once daily | Drug: Atorvastatin 5mg<br>* DW1125A<br>Drug: DW1125 placebo<br>* Ezetimibe/Atorvastatin 10/5 mg placebo<br>Drug: DW1125E placebo<br>* Ezetimibe 10mg placebo<br>Drug: DW1125A-1 placebo<br>* Atorvastatin 10mg placebo<br>|
| Placebo Comparator: DW1125E<br>1 Ezetimibe 10mg tablet orally once daily | Drug: Ezetimibe 10mg<br>* DW1125E<br>* Other names: Ezetrol Tab. 10mg;Drug: DW1125 placebo<br>* Ezetimibe/Atorvastatin 10/5 mg placebo<br>Drug: DW1125A placebo<br>* Atorvastatin 5mg placebo<br>Drug: DW1125A-1 placebo<br>* Atorvastatin 10mg placebo<br>|
| Placebo Comparator: DW1125A-1<br>1 Atorvastatin 10mg tablet orally once daily | Drug: Atorvastatin 10mg<br>* DW1125A-1<br>* Other names: Lipiwon Tab. 10mg;Drug: DW1125 placebo<br>* Ezetimibe/Atorvastatin 10/5 mg placebo<br>Drug: DW1125A placebo<br>* Atorvastatin 5mg placebo<br>Drug: DW1125E placebo<br>* Ezetimibe 10mg placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Change of LDL-C | % Change of LDL-C in week 8 from baseline | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Change of LDL-C | % Change of LDL-C in week 4 from baseline | 4 weeks | 
| % 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 | 
| 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 |