NCT05631990

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of AD-209

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_2

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

November 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

April 5, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

November 20, 2022

Last Update Submit

April 3, 2024

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)

Experimental 1

EXPERIMENTAL

AD-209, AD-209-1 placebo

Drug: AD-209Drug: AD-209-1 placebo

Experimental 2

EXPERIMENTAL

AD-209-1A, AD-209 placebo

Drug: AD-209-1ADrug: AD-209 placebo

Experimental 3

EXPERIMENTAL

AD-209-1B, AD-209 placebo

Drug: AD-209-1BDrug: AD-209 placebo

Experimental 4

EXPERIMENTAL

AD-209-1C, AD-209 placebo

Drug: AD-209-1CDrug: AD-209 placebo

Interventions

AD-209DRUG

PO, Once daily(QD), 8weeks

Experimental 1
AD-209-1ADRUG

PO, Once daily(QD), 8weeks

Experimental 2
AD-209-1BDRUG

PO, Once daily(QD), 8weeks

Experimental 3
AD-209-1CDRUG

PO, Once daily(QD), 8weeks

Experimental 4
AD-209 placeboDRUG

PO, Once daily(QD), 8weeks

Experimental 2Experimental 3Experimental 4
AD-209-1 placeboDRUG

PO, Once daily(QD), 8weeks

Experimental 1

Eligibility Criteria

Age19 Years - 74 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)

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Chang Gyu Park, M.D., Ph.D

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2022

First Posted

November 30, 2022

Study Start

April 5, 2023

Primary Completion

November 27, 2023

Study Completion

November 27, 2023

Last Updated

April 5, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)