NCT06291207

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of AD-224

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
252

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

February 27, 2024

Last Update Submit

February 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 (3)

AD-224A

EXPERIMENTAL

AD-224A+Placebo of AD-224B+Placebo of AD-224C

Drug: AD-224ADrug: Placebo of AD-224BDrug: Placebo of AD-224C

AD-224B

EXPERIMENTAL

Placebo of AD-224A+AD-224B+Placebo of AD-224C

Drug: AD-224BDrug: Placebo of AD-224ADrug: Placebo of AD-224C

AD-224C

ACTIVE COMPARATOR

Placebo of AD-224A+Placebo of AD-224B+AD-224C

Drug: AD-224CDrug: Placebo of AD-224ADrug: Placebo of AD-224B

Interventions

AD-224ADRUG

PO, Once daily, 8weeks

AD-224A
AD-224BDRUG

PO, Once daily, 8weeks

AD-224B
AD-224CDRUG

PO, Once daily, 8weeks

AD-224C
Placebo of AD-224ADRUG

PO, Once daily, 8weeks

AD-224BAD-224C
Placebo of AD-224BDRUG

PO, Once daily, 8weeks

AD-224AAD-224C
Placebo of AD-224CDRUG

PO, Once daily, 8weeks

AD-224AAD-224B

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent
  • Patients with Essential Hypertension

You may not qualify if:

  • Patient with Secondary Hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • InHo Chae, M.D., Ph.D

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JeongEun Park

CONTACT

+82-31-891-6989parkje@addpharma.co.kr

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

February 27, 2024

First Posted

March 4, 2024

Study Start

April 15, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

February 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)