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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04858308
Other study ID # YYPCT_YYC506_301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 29, 2021
Est. completion date January 31, 2022

Study information

Verified date April 2021
Source Yooyoung Pharmaceutical Co., Ltd.
Contact Seul Gi Ha, PM
Phone 82-2-6202-7105
Email sgha@yypharm.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase 3 study to evaluate the effiacay and safety of YYC506


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 554
Est. completion date January 31, 2022
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 17 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - History of Fibromyalgia, Myopathy etc (CK = 2XULN) - Uncontrolled hypo-thyroidism (TSH=1.5XULN) - Severe renal impairemnet (Creainine clearance < 30mL/min) etc.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
YYC506
YYC506
Control
Active control
YYC506 Placebo
Placebo
Control Placebo
Placebo

Locations

Country Name City State
Korea, Republic of Chonbuk National University Hospital Cheonju
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Seoul National UniversityHospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yooyoung Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent change (%) of non-HDL-C from baseline non HDL-C = TC - HDL-C from baseline at 12 weeks
Secondary Percent change (%) of non-HDL-C non HDL-C = TC - HDL-C from baseline at 4, 8, 14 weeks.
Secondary Percent change (%) of lipid parameters TC, HDL-C, LDL-C, TG from baseline at 4, 8, 12, 24 weeks
Secondary Percent change (%) of diabetes parameters FBS, HbA1c, Insulin from baseline at 4, 8, 12, 24 weeks
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