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Determining the Optimal Dose of AD-209 in Patients With Essential Hypertension

NCT ID: NCT04218552

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-25

Study Completion Date

2021-02-25

Brief Summary

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

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Detailed Description

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Condition or disease : hypertension Intervention/treatment Drug : AD-209-H Drug : AD-209-M Drug : AD-209-L Drug : Placebo Drug : Amlodipine Drug : Telmisartan Phase : Phase 2

Conditions

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Hypertension,Essential

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental 1

AD-209 High

Group Type EXPERIMENTAL

AD209

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Experimental 2

AD-209 Middle

Group Type EXPERIMENTAL

AD209

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Experimental 3

AD-209 Low

Group Type EXPERIMENTAL

AD209

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Active Comparator 1

Amlodipine Low

Group Type ACTIVE_COMPARATOR

Amlodipine low

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Active Comparator 2

Amlodipine High

Group Type ACTIVE_COMPARATOR

Amlodipine high

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Active Comparator 3

Telmisartan

Group Type ACTIVE_COMPARATOR

Telmisartan

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Placebo comparator

Placebo

Group Type PLACEBO_COMPARATOR

AD209

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Amlodipine low

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Amlodipine high

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Telmisartan

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Interventions

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AD209

PO, Once daily(QD), 8weeks

Intervention Type DRUG

Amlodipine low

PO, Once daily(QD), 8weeks

Intervention Type DRUG

Amlodipine high

PO, Once daily(QD), 8weeks

Intervention Type DRUG

Telmisartan

PO, Once daily(QD), 8weeks

Intervention Type DRUG

Other Intervention Names

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AD209 Placebo Amlodipine low placebo Amlodipine high placebo Telmisartan placebo

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Other inclusions applied

Exclusion Criteria

* orthostatic hypotension with symptom
* Other exclusions applied
Minimum Eligible Age

19 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ChangGu Park, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Korea University Guro Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 36094783 (View on PubMed)

Other Identifiers

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AD-209P2

Identifier Type: -

Identifier Source: org_study_id

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