Back to resultsA Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A
Primary Purpose
Primary Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-221
AD-221A
AD-221B
AD-221C
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent
- Subjects with primary hypercholesterolemia
Exclusion Criteria:
- Patient with secondary dyslipidemia
- Other exclusions applied
Sites / Locations
- Yonsei University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
AD-221
AD-221A
AD-221B
AD-221C
Arm Description
AD-221, Placebo of AD-221A, AD-221B and AD-221C
AD-221A, Placebo of AD-221, AD-221B and AD-221C
AD-221B, Placebo of AD-221, AD-221A and AD-221C
AD-221C, Placebo of AD-221, AD-221A and AD-221B
Outcomes
Primary Outcome Measures
Low density lipoprotein cholesterol (LDL-C)
LDL-C change at Week 8
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05131997
Brief Title
A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A
Official Title
A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Administrated AD-221 and AD-221A in Patients With Primary Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
June 8, 2022 (Actual)
Study Completion Date
June 8, 2022 (Actual)
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-221 and AD-221A
Detailed Description
The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A in patients with primary hypercholesterolemia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AD-221
Arm Type
Experimental
Arm Description
AD-221, Placebo of AD-221A, AD-221B and AD-221C
Arm Title
AD-221A
Arm Type
Experimental
Arm Description
AD-221A, Placebo of AD-221, AD-221B and AD-221C
Arm Title
AD-221B
Arm Type
Active Comparator
Arm Description
AD-221B, Placebo of AD-221, AD-221A and AD-221C
Arm Title
AD-221C
Arm Type
Active Comparator
Arm Description
AD-221C, Placebo of AD-221, AD-221A and AD-221B
Intervention Type
Drug
Intervention Name(s)
AD-221
Intervention Description
PO, Once daily(QD), 8 weeks
Intervention Type
Drug
Intervention Name(s)
AD-221A
Intervention Description
PO, Once daily(QD), 8 weeks
Intervention Type
Drug
Intervention Name(s)
AD-221B
Other Intervention Name(s)
Ezetimibe
Intervention Description
PO, Once daily(QD), 8 weeks
Intervention Type
Drug
Intervention Name(s)
AD-221C
Other Intervention Name(s)
Atorvastatin
Intervention Description
PO, Once daily(QD), 8 weeks
Primary Outcome Measure Information:
Title
Low density lipoprotein cholesterol (LDL-C)
Description
LDL-C change at Week 8
Time Frame
Baseline, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent
Subjects with primary hypercholesterolemia
Exclusion Criteria:
Patient with secondary dyslipidemia
Other exclusions applied
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Hak Lee, M.D., Ph.D
Organizational Affiliation
Yonsei University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Hospital
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A
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