Status:
COMPLETED
Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A
Lead Sponsor:
Daewon Pharmaceutical Co., Ltd.
Conditions:
Hypercholesterolemia, Dyslipidemia
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2023
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT05970679
Start Date
August 17 2022
End Date
April 13 2023
Last Update
August 1 2023
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea