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Recruiting NCT05400317

A Study to Evaluate the Efficacy and Safety of AD-218

Phase III Interventional Mixed Dyslipidemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AD-218, AD-218A.
Who it may be relevant to
Registry conditions: Mixed Dyslipidemia. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Drug AD-218
    PO, Once daily(QD), 12weeks
  • Drug AD-218A
    PO, Once daily(QD), 12weeks

Primary outcome measures

  • Percent change (%) of non-HDL-C from baseline at week 12 [Time frame: from baseline at 12 weeks]
Secondary outcome measures (2)
  • Percent change (%) of non-HDL-C from baseline at week 4, 8 [Time frame: from baseline at week 4,8]
  • Percent change (%) of Lipid panel from baseline at week 4, 8, 12 [Time frame: from baseline at week 4, 8, 12]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Yeongnam University Hospital — Daegu

Identifiers

NCT: NCT05400317 · AD-218P3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗