NCT06052748

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of AD-223

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

September 19, 2023

Last Update Submit

April 2, 2025

Conditions

Hypertension,Essential

Outcome Measures

Primary Outcomes (1)

  • Change rate of MSSBP

    Change from baseline in mean sitting systolic blood pressure

    Baseline, Week 8

Study Arms (4)

Test group

EXPERIMENTAL

AD-223A+AD-223B+AD-223C Placebo

Drug: AD-223ADrug: AD-223BDrug: AD-223C Placebo

Control group 1

ACTIVE COMPARATOR

AD-223A+AD-223B Placebo+AD-223C Placebo

Drug: AD-223ADrug: AD-223B PlaceboDrug: AD-223C Placebo

Control group 2

ACTIVE COMPARATOR

AD-223A Placebo+AD-223B+AD-223C Placebo

Drug: AD-223BDrug: AD-223A PlaceboDrug: AD-223C Placebo

Control group 3

ACTIVE COMPARATOR

AD-223A Placebo+AD-223B Placebo+AD-223C

Drug: AD-223CDrug: AD-223A PlaceboDrug: AD-223B Placebo

Interventions

AD-223ADRUG

PO, Once daily(QD), 8weeks

Control group 1Test group
AD-223BDRUG

PO, Once daily(QD), 8weeks

Control group 2Test group
AD-223CDRUG

PO, Once daily(QD), 8weeks

Control group 3
AD-223A PlaceboDRUG

PO, Once daily(QD), 8weeks

Control group 2Control group 3
AD-223B PlaceboDRUG

PO, Once daily(QD), 8weeks

Control group 1Control group 3
AD-223C PlaceboDRUG

PO, Once daily(QD), 8weeks

Control group 1Control group 2Test group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent

You may not qualify if:

  • Orthostatic hypotension with symptom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Jin Ho Shin, M.D., Ph.D

    Hanyang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 25, 2023

Study Start

February 15, 2024

Primary Completion

March 27, 2025

Study Completion

April 2, 2025

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)