Back to resultsA Study to Evaluate the Efficacy and Safety of AD-218
Primary Purpose
Mixed Dyslipidemia
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-218
AD-218A
Sponsored by
About this trial
This is an interventional treatment trial for Mixed Dyslipidemia
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
Sites / Locations
- Yeongnam University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active Comparator : Test group
Active Comparator : Control group
Arm Description
AD-218
AD-218A
Outcomes
Primary Outcome Measures
Percent change (%) of non-HDL-C from baseline at week 12
non-HDL-C at week 12 compared AD-218 with AD-218A
Secondary Outcome Measures
Percent change (%) of non-HDL-C from baseline at week 4, 8
non-HDL-C at week 4,8 compared AD-218 with AD-218A
Percent change (%) of Lipid panel from baseline at week 4, 8, 12
Lipid panel at week 4, 8, 12 compared AD-218 with AD-218A
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05400317
Brief Title
A Study to Evaluate the Efficacy and Safety of AD-218
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
520 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator : Test group
Arm Type
Experimental
Arm Description
AD-218
Arm Title
Active Comparator : Control group
Arm Type
Active Comparator
Arm Description
AD-218A
Intervention Type
Drug
Intervention Name(s)
AD-218
Intervention Description
PO, Once daily(QD), 12weeks
Intervention Type
Drug
Intervention Name(s)
AD-218A
Intervention Description
PO, Once daily(QD), 12weeks
Primary Outcome Measure Information:
Title
Percent change (%) of non-HDL-C from baseline at week 12
Description
non-HDL-C at week 12 compared AD-218 with AD-218A
Time Frame
from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Percent change (%) of non-HDL-C from baseline at week 4, 8
Description
non-HDL-C at week 4,8 compared AD-218 with AD-218A
Time Frame
from baseline at week 4,8
Title
Percent change (%) of Lipid panel from baseline at week 4, 8, 12
Description
Lipid panel at week 4, 8, 12 compared AD-218 with AD-218A
Time Frame
from baseline at week 4, 8, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Yoon
Phone
82-031-891-5576
Email
sryoon@addpharma.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Kyu Chang Won, M.D., Ph.D
Facility Information:
Facility Name
Yeongnam University Hospital
City
Daegu
State/Province
Nam-gu
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyu Chang Won, M.D., Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of AD-218
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