Phase III Study to Evaluate the Efficacy and Safety of AD-209

NCT ID: NCT06348576

Last Updated: 2024-05-21

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

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2025-02-28

Brief Summary

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

Detailed Description

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Condition or disease : hypertension

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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Test group

AD-209+AD-2091 Placebo

Group Type EXPERIMENTAL

AD-209

Intervention Type DRUG

PO, Once daily(QD), 8weeks

AD-2091 Placebo

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Control group

AD-2091+AD-209 Placebo

Group Type ACTIVE_COMPARATOR

AD-2091

Intervention Type DRUG

PO, Once daily(QD), 8weeks

AD-209 Placebo

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Interventions

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AD-209

PO, Once daily(QD), 8weeks

Intervention Type DRUG

AD-2091

PO, Once daily(QD), 8weeks

Intervention Type DRUG

AD-209 Placebo

PO, Once daily(QD), 8weeks

Intervention Type DRUG

AD-2091 Placebo

PO, Once daily(QD), 8weeks

Intervention Type DRUG

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

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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Chang Gyu 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 RECRUITING

Countries

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South Korea

Central Contacts

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Kyung Tae Kim, D.V.M

Role: CONTACT

82-031-891-5661

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

Role: CONTACT

Facility Contacts

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

Role: primary

Other Identifiers

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AD-209P3

Identifier Type: -

Identifier Source: org_study_id

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