NCT04218552

Brief Summary

The purpose of this study is to determine the optimal dose of AD-209 in patients with Essential Hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2020

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

January 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 25, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
Last Updated

July 21, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

January 3, 2020

Last Update Submit

July 20, 2021

Conditions

Hypertension,Essential

Outcome Measures

Primary Outcomes (1)

  • 1. Change rate of MSSBP

    Change from baseline in mean sitting systolic blood pressure

    [ Time Frame: baseline, 8 weeks ]

Secondary Outcomes (4)

  • 1. Change rate of MSSBP

    [ Time Frame: baseline, 4 weeks ]

  • 2. Change rate of MSDBP

    [ Time Frame: baseline, 4 weeks, 8 weeks ]

  • 3. Proportion of BP normalization MSSBP/MSDBP < 140/90 mmHg MSSBP/MSDBP < 130/80 mmHg (Diabetes or Chronic renal disease)

    [ Time Frame: 4 weeks, 8 weeks ]

  • 4.Reaction rate of BP

    [ Time Frame: baseline, 4 weeks, 8 weeks ]

Study Arms (7)

Experimental 1

EXPERIMENTAL

AD-209 High

Drug: AD209

Experimental 2

EXPERIMENTAL

AD-209 Middle

Drug: AD209

Experimental 3

EXPERIMENTAL

AD-209 Low

Drug: AD209

Active Comparator 1

ACTIVE COMPARATOR

Amlodipine Low

Drug: Amlodipine low

Active Comparator 2

ACTIVE COMPARATOR

Amlodipine High

Drug: Amlodipine high

Active Comparator 3

ACTIVE COMPARATOR

Telmisartan

Drug: Telmisartan

Placebo comparator

PLACEBO COMPARATOR

Placebo

Drug: AD209Drug: Amlodipine lowDrug: Amlodipine highDrug: Telmisartan

Interventions

AD209DRUG

PO, Once daily(QD), 8weeks

Also known as: AD209 Placebo
Experimental 1Experimental 2Experimental 3Placebo comparator
Amlodipine lowDRUG

PO, Once daily(QD), 8weeks

Also known as: Amlodipine low placebo
Active Comparator 1Placebo comparator
Amlodipine highDRUG

PO, Once daily(QD), 8weeks

Also known as: Amlodipine high placebo
Active Comparator 2Placebo comparator
TelmisartanDRUG

PO, Once daily(QD), 8weeks

Also known as: Telmisartan placebo
Active Comparator 3Placebo comparator

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

Related Publications (1)

  • Sung KC, Sung JH, Cho EJ, Ahn JC, Han SH, Kim W, Kim KH, Sohn IS, Shin J, Kim SY, Kim KI, Kang SM, Park SJ, Kim YJ, Shin JH, Park SM, Park CG. Efficacy and safety of low-dose antihypertensive combination of amlodipine, telmisartan, and chlorthalidone: A randomized, double-blind, parallel, phase II trial. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1298-1309. doi: 10.1111/jch.14570. Epub 2022 Sep 12.

    PMID: 36094783DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • ChangGu 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

January 3, 2020

First Posted

January 6, 2020

Study Start

February 25, 2020

Primary Completion

February 25, 2021

Study Completion

February 25, 2021

Last Updated

July 21, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)