NCT06441630

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of co-administration of AD-227A and AD-227B in patients with essential hypertension

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
251

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

May 29, 2024

Last Update Submit

February 2, 2025

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in MSSBP

    Change from Baseline in Mean Sitting Systolic Blood Pressure

    Baseline to Week8

Study Arms (3)

Co-administration of AD-227A and AD-227B

EXPERIMENTAL

AD-227A + AD-227B + Placebo of AD-227C

Drug: AD-227ADrug: AD-227BDrug: Placebo of AD-227C

AD-227A

ACTIVE COMPARATOR

AD-227A + Placebo of AD-227B + Placebo of AD-227C

Drug: AD-227ADrug: Placebo of AD-227BDrug: Placebo of AD-227C

Co-administration of AD-227A and AD-227C

ACTIVE COMPARATOR

AD-227A + Placebo of AD-227B + AD-227C

Drug: AD-227ADrug: AD-227CDrug: Placebo of AD-227B

Interventions

AD-227ADRUG

Per Oral, 1 Tablet, Once a day for 8 weeks

AD-227ACo-administration of AD-227A and AD-227BCo-administration of AD-227A and AD-227C
AD-227BDRUG

Per Oral, 1 Tablet, Once a day for 8 weeks

Co-administration of AD-227A and AD-227B
AD-227CDRUG

Per Oral, 1 Tablet, Once a day for 8 weeks

Co-administration of AD-227A and AD-227C
Placebo of AD-227BDRUG

Per Oral, 1 Tablet, Once a day for 8 weeks

AD-227ACo-administration of AD-227A and AD-227C
Placebo of AD-227CDRUG

Per Oral, 1 Tablet, Once a day for 8 weeks

AD-227ACo-administration of AD-227A and AD-227B

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)

Gangnam CHA Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Chong-Jin Kim

    Gangnam CHA Medical Center

    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

May 29, 2024

First Posted

June 4, 2024

Study Start

July 31, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

February 4, 2025

Record last verified: 2025-02

Locations

KR(1)