A Study to Evaluate the Efficacy and Safety of Co-administration of AD-227A and AD-227B

NCT ID: NCT06441630

Last Updated: 2025-02-04

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

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-09-30

Brief Summary

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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

Detailed Description

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Essential Hypertension

Conditions

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Essential Hypertension

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

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

Group Type EXPERIMENTAL

AD-227A

Intervention Type DRUG

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

AD-227B

Intervention Type DRUG

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

Placebo of AD-227C

Intervention Type DRUG

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

AD-227A

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

Group Type ACTIVE_COMPARATOR

AD-227A

Intervention Type DRUG

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

Placebo of AD-227B

Intervention Type DRUG

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

Placebo of AD-227C

Intervention Type DRUG

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

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

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

Group Type ACTIVE_COMPARATOR

AD-227A

Intervention Type DRUG

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

AD-227C

Intervention Type DRUG

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

Placebo of AD-227B

Intervention Type DRUG

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

Interventions

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AD-227A

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

Intervention Type DRUG

AD-227B

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

Intervention Type DRUG

AD-227C

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

Intervention Type DRUG

Placebo of AD-227B

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

Intervention Type DRUG

Placebo of AD-227C

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Patients with Essential Hypertension
* Other inclusions applied

Exclusion Criteria

* Patient with Secondary Hypertension
* 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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Chong-Jin Kim

Role: PRINCIPAL_INVESTIGATOR

Gangnam CHA Medical Center

Locations

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Gangnam CHA Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JeongEun Park

Role: CONTACT

+82-31-891-6989

Other Identifiers

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AD-227P3

Identifier Type: -

Identifier Source: org_study_id

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