Back to resultsA Study to Evaluate the Efficacy and Safety of AD-223
Primary Purpose
Hypertension,Essential
Status
Not yet recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-223A
AD-223B
AD-223C
AD-223A Placebo
AD-223B Placebo
AD-223C Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension,Essential
Eligibility Criteria
Inclusion Criteria: Signed informed consent Other inclusions applied Exclusion Criteria: Orthostatic hypotension with symptom Other exclusions applied
Sites / Locations
- Hanyang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
Test group
Control group 1
Control group 2
Control group 3
Arm Description
AD-223A+AD-223B+AD-223C Placebo
AD-223A+AD-223B Placebo+AD-223C Placebo
AD-223A Placebo+AD-223B+AD-223C Placebo
AD-223A Placebo+AD-223B Placebo+AD-223C
Outcomes
Primary Outcome Measures
Change rate of MSSBP
Change from baseline in mean sitting systolic blood pressure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06052748
Brief Title
A Study to Evaluate the Efficacy and Safety of AD-223
Official Title
A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-223A and AD-223B Combination Therapy in Patients With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (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-223
Detailed Description
Condition or disease : hypertension
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
486 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Description
AD-223A+AD-223B+AD-223C Placebo
Arm Title
Control group 1
Arm Type
Active Comparator
Arm Description
AD-223A+AD-223B Placebo+AD-223C Placebo
Arm Title
Control group 2
Arm Type
Active Comparator
Arm Description
AD-223A Placebo+AD-223B+AD-223C Placebo
Arm Title
Control group 3
Arm Type
Active Comparator
Arm Description
AD-223A Placebo+AD-223B Placebo+AD-223C
Intervention Type
Drug
Intervention Name(s)
AD-223A
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
AD-223B
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
AD-223C
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
AD-223A Placebo
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
AD-223B Placebo
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
AD-223C Placebo
Intervention Description
PO, Once daily(QD), 8weeks
Primary Outcome Measure Information:
Title
Change rate of MSSBP
Description
Change from baseline in mean sitting systolic blood pressure
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
Other inclusions applied
Exclusion Criteria:
Orthostatic hypotension with symptom
Other exclusions applied
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung Tae Kim, D.V.M
Phone
82-031-891-5661
Email
ktkim@addpharma.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Ho Shin, M.D., Ph.D
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Ho Shin, M.D., Ph.D
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Ho Shin, M.D., Ph.D
First Name & Middle Initial & Last Name & Degree
Jin Ho Shin, 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-223
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