A Study to Evaluate the Efficacy and Safety of AD-223

January 29, 2024 updated by: Addpharma Inc.

A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-223A and AD-223B Combination Therapy in Patients With Essential Hypertension

The purpose of this study is to evaluate the efficacy and safety of AD-223

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Condition or disease : hypertension

Study Type

Interventional

Enrollment (Estimated)

486

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jin Ho Shin, M.D., Ph.D

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Hanyang University Hospital
        • Contact:
          • Jin Ho Shin, M.D., Ph.D
        • Principal Investigator:
          • Jin Ho Shin, M.D., Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent
  • Other inclusions applied

Exclusion Criteria:

  • Orthostatic hypotension with symptom
  • Other exclusions applied

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
AD-223A+AD-223B+AD-223C Placebo
Drug: AD-223A
PO, Once daily(QD), 8weeks
Drug: AD-223B
PO, Once daily(QD), 8weeks
Drug: AD-223C Placebo
PO, Once daily(QD), 8weeks
Active Comparator: Control group 1
AD-223A+AD-223B Placebo+AD-223C Placebo
Drug: AD-223A
PO, Once daily(QD), 8weeks
Drug: AD-223C Placebo
PO, Once daily(QD), 8weeks
Drug: AD-223B Placebo
PO, Once daily(QD), 8weeks
Active Comparator: Control group 2
AD-223A Placebo+AD-223B+AD-223C Placebo
Drug: AD-223B
PO, Once daily(QD), 8weeks
Drug: AD-223C Placebo
PO, Once daily(QD), 8weeks
Drug: AD-223A Placebo
PO, Once daily(QD), 8weeks
Active Comparator: Control group 3
AD-223A Placebo+AD-223B Placebo+AD-223C
Drug: AD-223B Placebo
PO, Once daily(QD), 8weeks
Drug: AD-223A Placebo
PO, Once daily(QD), 8weeks
Drug: AD-223C
PO, Once daily(QD), 8weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change rate of MSSBP
Time Frame: Baseline, Week 8
Change from baseline in mean sitting systolic blood pressure
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Investigators

  • Principal Investigator: Jin Ho Shin, M.D., Ph.D, Hanyang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-223P3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension,Essential

Clinical Trials on AD-223A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe