NCT06348576

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 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

April 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

April 1, 2024

Last Update Submit

May 19, 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 (2)

Test group

EXPERIMENTAL

AD-209+AD-2091 Placebo

Drug: AD-209Drug: AD-2091 Placebo

Control group

ACTIVE COMPARATOR

AD-2091+AD-209 Placebo

Drug: AD-2091Drug: AD-209 Placebo

Interventions

AD-209DRUG

PO, Once daily(QD), 8weeks

Test group
AD-2091DRUG

PO, Once daily(QD), 8weeks

Control group
AD-209 PlaceboDRUG

PO, Once daily(QD), 8weeks

Control group
AD-2091 PlaceboDRUG

PO, Once daily(QD), 8weeks

Test 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)

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

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

Central Study Contacts

Kyung Tae Kim, D.V.M

CONTACT

82-031-891-5661ktkim@addpharma.co.kr

Chang Gyu Park, M.D., Ph.D

CONTACT

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

April 1, 2024

First Posted

April 4, 2024

Study Start

May 20, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

May 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)