Dyslipidemias
Conditions
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.
Interventions
Sponsors
Yooyoung Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind.
Intervention model description
A multicenter, Double-blind, Randomized, Active-controlled, Double dummy, Parelle-group comparative.
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change (%) of non-HDL-C from baseline | from baseline at 12 weeks | non HDL-C = TC - HDL-C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change (%) of non-HDL-C | from baseline at 4, 8, 14 weeks. | non HDL-C = TC - HDL-C |
| Percent change (%) of lipid parameters | from baseline at 4, 8, 12, 24 weeks | TC, HDL-C, LDL-C, TG |
| Percent change (%) of diabetes parameters | from baseline at 4, 8, 12, 24 weeks | FBS, HbA1c, Insulin |
Countries
South Korea
Contacts
Primary ContactSeul Gi Ha, PM
Outcome results
None listed