Status:
UNKNOWN
Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.
Lead Sponsor:
Yooyoung Pharmaceutical Co., Ltd.
Conditions:
Dyslipidemias
Eligibility:
All Genders
17+ years
Phase:
PHASE3
Brief Summary
Phase 3 study to evaluate the effiacay and safety of YYC506
Detailed Description
Phase 3 study to evaluate the effiacay and safety of YYC506 in patients with complex dyslipidemia where LDL-C is properly controlled but TG and HDL-C levels are not regulated by Atorvastatin alone.
Eligibility Criteria
Inclusion
- A man or woman over 19 years old.
- LDL-C properly controlled, TG, HDL-C is not properly controlled
- Sign on ICF prior to study participation
Exclusion
- History of Fibromyalgia, Myopathy etc (CK ≥ 2XULN)
- Uncontrolled hypo-thyroidism (TSH≥1.5XULN)
- Severe renal impairemnet (Creainine clearance \< 30mL/min) etc.
Key Trial Info
Start Date :
January 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2022
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT04858308
Start Date
January 29 2021
End Date
January 31 2022
Last Update
April 26 2021
Active Locations (3)
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1
Chonbuk National University Hospital
Cheonju, South Korea
2
Seoul National University Bundang Hospital
Seongnam-si, South Korea
3
Seoul National UniversityHospital
Seoul, South Korea