A Study to Evaluate the Efficacy and Safety of AD-224

March 3, 2024 updated by: Addpharma Inc.

A Randomization, Double-blind, Active-controlled, Multicenter, Phase 3 Trial to Evaluate the Efficacy and Safety of AD-224A and AD-224B in Patients With Essential Hypertension

The purpose of this study is to evaluate the efficacy and safety of AD-224

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Condition or disease : Essential Hypertension

Study Type

Interventional

Enrollment (Estimated)

252

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

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
  • Patients with Essential Hypertension
  • Other inclusions applied

Exclusion Criteria:

  • Patient with Secondary Hypertension
  • 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: AD-224A
AD-224A+Placebo of AD-224B+Placebo of AD-224C
Drug: AD-224A
PO, Once daily, 8weeks
Drug: Placebo of AD-224B
PO, Once daily, 8weeks
Drug: Placebo of AD-224C
PO, Once daily, 8weeks
Experimental: AD-224B
Placebo of AD-224A+AD-224B+Placebo of AD-224C
Drug: AD-224B
PO, Once daily, 8weeks
Drug: Placebo of AD-224C
PO, Once daily, 8weeks
Drug: Placebo of AD-224A
PO, Once daily, 8weeks
Active Comparator: AD-224C
Placebo of AD-224A+Placebo of AD-224B+AD-224C
Drug: AD-224C
PO, Once daily, 8weeks
Drug: Placebo of AD-224B
PO, Once daily, 8weeks
Drug: Placebo of AD-224A
PO, Once daily, 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: InHo Chae, M.D., Ph.D, Seoul National University Bundang Hospital

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)

April 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-224P3

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.

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