Mixed Dyslipidemia
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of AD-218
Detailed description
Condition or disease : Mixed Dyslipidemia Treatment Drug : AD-218, AD-218A, Placebo of AD-218, Placebo of AD-218A
Interventions
DRUGAD-218
PO, Once daily(QD), 12weeks
DRUGAD-218A
PO, Once daily(QD), 12weeks
Sponsors
Addpharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A man or woman over 19 years old. * Sign on ICF prior to study participation
Exclusion criteria
* History of Fibromyalgia, Myopathy etc (CK ≥ 2 X ULN) * Other exclusions applied
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change (%) of non-HDL-C from baseline at week 12 | from baseline at 12 weeks | non-HDL-C at week 12 compared AD-218 with AD-218A |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change (%) of non-HDL-C from baseline at week 4, 8 | from baseline at week 4,8 | non-HDL-C at week 4,8 compared AD-218 with AD-218A |
| Percent change (%) of Lipid panel from baseline at week 4, 8, 12 | from baseline at week 4, 8, 12 | Lipid panel at week 4, 8, 12 compared AD-218 with AD-218A |
Countries
South Korea
Contacts
Primary ContactSarah Yoon
Backup ContactKyu Chang Won, M.D., Ph.D
Outcome results
None listed