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Completed

NCT Number: NCT05970679

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

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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Key information

Conditions

Hypercholesterolemia, Dyslipidemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ezetimibe/Atorvastatin 10/5 mg

Drug

DW1125

Atorvastatin 5mg

Drug

DW1125A

Ezetimibe 10mg

Drug

DW1125E

Other names: Ezetrol Tab. 10mg

Atorvastatin 10mg

Drug

DW1125A-1

Other names: Lipiwon Tab. 10mg

DW1125 placebo

Drug

Ezetimibe/Atorvastatin 10/5 mg placebo

DW1125A placebo

Drug

Atorvastatin 5mg placebo

DW1125E placebo

Drug

Ezetimibe 10mg placebo

DW1125A-1 placebo

Drug

Atorvastatin 10mg placebo

Primary outcomes

  1. % Change of LDL-C

    Time frame: 8 weeks

    % Change of LDL-C in week 8 from baseline

Secondary outcomes

  1. % Change of LDL-C

    Time frame: 4 weeks

    % Change of LDL-C in week 4 from baseline

  2. % Change of Lipid parameters

    Time frame: 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

  3. LDL-C goal achievement rates

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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