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

January 29, 2024 updated by: Addpharma Inc.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kyu Chang Won, M.D., Ph.D

Study Locations

  • Korea, Republic of
    • Nam-gu
      • Daegu, Nam-gu, Korea, Republic of, 42415
        • Recruiting
        • Yeongnam University Hospital
        • Contact:
          • Kyu Chang Won, M.D., Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Comparator : Test group
AD-218
Drug: AD-218
PO, Once daily(QD), 12weeks
Active Comparator: Active Comparator : Control group
AD-218A
Drug: AD-218A
PO, Once daily(QD), 12weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Lipid panel at week 4, 8, 12 compared AD-218 with AD-218A
from baseline at week 4, 8, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Investigators

  • Principal Investigator: Kyu Chang Won, M.D., Ph.D, Yeungnam University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2022

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-218P3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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