Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A (NCT05970679) | Clinical Trial Compass
CompletedPhase 3
Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A
South Korea252 participantsStarted 2022-08-17
Plain-language 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
Who can participate
Age range19 Years
SexALL
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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