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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-17

Study Completion Date

2023-04-13

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

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Detailed Description

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Conditions

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Hypercholesterolemia, Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DW1125

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

Group Type EXPERIMENTAL

Ezetimibe/Atorvastatin 10/5 mg

Intervention Type DRUG

DW1125

DW1125A placebo

Intervention Type DRUG

Atorvastatin 5mg placebo

DW1125E placebo

Intervention Type DRUG

Ezetimibe 10mg placebo

DW1125A-1 placebo

Intervention Type DRUG

Atorvastatin 10mg placebo

DW1125A

1 Atorvastatin 5 mg tablet orally once daily

Group Type EXPERIMENTAL

Atorvastatin 5mg

Intervention Type DRUG

DW1125A

DW1125 placebo

Intervention Type DRUG

Ezetimibe/Atorvastatin 10/5 mg placebo

DW1125E placebo

Intervention Type DRUG

Ezetimibe 10mg placebo

DW1125A-1 placebo

Intervention Type DRUG

Atorvastatin 10mg placebo

DW1125E

1 Ezetimibe 10mg tablet orally once daily

Group Type PLACEBO_COMPARATOR

Ezetimibe 10mg

Intervention Type DRUG

DW1125E

DW1125 placebo

Intervention Type DRUG

Ezetimibe/Atorvastatin 10/5 mg placebo

DW1125A placebo

Intervention Type DRUG

Atorvastatin 5mg placebo

DW1125A-1 placebo

Intervention Type DRUG

Atorvastatin 10mg placebo

DW1125A-1

1 Atorvastatin 10mg tablet orally once daily

Group Type PLACEBO_COMPARATOR

Atorvastatin 10mg

Intervention Type DRUG

DW1125A-1

DW1125 placebo

Intervention Type DRUG

Ezetimibe/Atorvastatin 10/5 mg placebo

DW1125A placebo

Intervention Type DRUG

Atorvastatin 5mg placebo

DW1125E placebo

Intervention Type DRUG

Ezetimibe 10mg placebo

Interventions

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Ezetimibe/Atorvastatin 10/5 mg

DW1125

Intervention Type DRUG

Atorvastatin 5mg

DW1125A

Intervention Type DRUG

Ezetimibe 10mg

DW1125E

Intervention Type DRUG

Atorvastatin 10mg

DW1125A-1

Intervention Type DRUG

DW1125 placebo

Ezetimibe/Atorvastatin 10/5 mg placebo

Intervention Type DRUG

DW1125A placebo

Atorvastatin 5mg placebo

Intervention Type DRUG

DW1125E placebo

Ezetimibe 10mg placebo

Intervention Type DRUG

DW1125A-1 placebo

Atorvastatin 10mg placebo

Intervention Type DRUG

Other Intervention Names

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Ezetrol Tab. 10mg Lipiwon Tab. 10mg

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No