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

NCT ID: NCT05400317

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-27

Study Completion Date

2026-06-30

Brief Summary

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

Detailed Description

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

Conditions

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Mixed Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active Comparator : Test group

AD-218

Group Type EXPERIMENTAL

AD-218

Intervention Type DRUG

PO, Once daily(QD), 12weeks

Active Comparator : Control group

AD-218A

Group Type ACTIVE_COMPARATOR

AD-218A

Intervention Type DRUG

PO, Once daily(QD), 12weeks

Interventions

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AD-218

PO, Once daily(QD), 12weeks

Intervention Type DRUG

AD-218A

PO, Once daily(QD), 12weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Yeungnam University Hospital

Locations

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Yeongnam University Hospital

Daegu, Nam-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sarah Yoon

Role: CONTACT

82-031-891-5576

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

Role: CONTACT

Facility Contacts

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

Role: primary

Other Identifiers

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AD-218P3

Identifier Type: -

Identifier Source: org_study_id

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