Evaluating the effectiveness and safety of AD-218 for mixed dyslipidemia
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
This study is testing if a new drug called AD-218 can help people with mixed dyslipidemia improve their cholesterol levels and overall health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 520 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Addpharma Inc. Industry-sponsored |
| Locations | 1 site (Daegu, Nam-gu) |
| Trial ID | NCT05400317 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of the drug AD-218 in patients with mixed dyslipidemia. Participants will receive either AD-218, AD-218A, or a placebo to determine the drug's impact on lipid levels and overall health. The study will involve individuals over 19 years old who meet specific inclusion criteria and will exclude those with certain medical histories. The trial is designed to provide robust data on the effectiveness of AD-218 in managing mixed dyslipidemia.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 19 years old diagnosed with mixed dyslipidemia.
Not a fit: Patients with a history of fibromyalgia, myopathy, or elevated creatine kinase levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients with mixed dyslipidemia, improving their lipid profiles and reducing cardiovascular risks.
How similar studies have performed: Other studies have shown promise in treating mixed dyslipidemia with similar pharmacological approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Daegu, Nam-gu
- Yeongnam University Hospital — Daegu, Nam-gu, South Korea (Recruiting)
Study contacts
- Principal investigator: Kyu Chang Won, M.D., Ph.D — Yeungnam University Hospital
- Study coordinator: Sarah Yoon
- Email: sryoon@addpharma.co.kr
- Phone: 82-031-891-5576
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.