Mixed Dyslipidemia Clinical Trial
Official title:
A Randomized, Double-blinded, Active-controlled, Multicenter Phase 3 Clinical Trial and Open-label, Extension Study to Evaluate the Efficacy and Safety of AD-218 in Patients With Mixed Dyslipidemia
The purpose of this study is to evaluate the efficacy and safety of AD-218
| Status | Recruiting |
| Enrollment | 520 |
| Est. completion date | June 30, 2025 |
| Est. primary completion date | March 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Yeongnam University Hospital | Daegu | Nam-gu |
| Lead Sponsor | Collaborator |
|---|---|
| Addpharma Inc. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent change (%) of non-HDL-C from baseline at week 12 | non-HDL-C at week 12 compared AD-218 with AD-218A | from baseline at 12 weeks | |
| Secondary | Percent change (%) of non-HDL-C from baseline at week 4, 8 | non-HDL-C at week 4,8 compared AD-218 with AD-218A | from baseline at week 4,8 | |
| Secondary | Percent change (%) of Lipid panel from baseline at week 4, 8, 12 | Lipid panel at week 4, 8, 12 compared AD-218 with AD-218A | from baseline at week 4, 8, 12 |
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