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Recruiting

NCT Number: NCT05400317

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

The purpose of this study is to evaluate the efficacy and safety of AD-218

Recruiting

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Key information

Conditions

Mixed Dyslipidemia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yeongnam University Hospital

Daegu, Nam-gu, 42415, South Korea

Location status: Recruiting

Location contact

Kyu Chang Won, M.D., Ph.D

CONTACT

About this study

Condition or disease : Mixed Dyslipidemia Treatment Drug : AD-218, AD-218A, Placebo of AD-218, Placebo of AD-218A

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AD-218

Drug

PO, Once daily(QD), 12weeks

AD-218A

Drug

PO, Once daily(QD), 12weeks

Primary outcomes

  1. Percent change (%) of non-HDL-C from baseline at week 12

    Time frame: from baseline at 12 weeks

    non-HDL-C at week 12 compared AD-218 with AD-218A

Secondary outcomes

  1. Percent change (%) of non-HDL-C from baseline at week 4, 8

    Time frame: from baseline at week 4,8

    non-HDL-C at week 4,8 compared AD-218 with AD-218A

  2. Percent change (%) of Lipid panel from baseline at week 4, 8, 12

    Time frame: from baseline at week 4, 8, 12

    Lipid panel at week 4, 8, 12 compared AD-218 with AD-218A

Study contacts

Contact information is provided by the study sponsor or research team.

Kyu Chang Won, M.D., Ph.D

CONTACT

Sarah Yoon

CONTACT

[email protected]

82-031-891-5576

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2022
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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