A Study to Evaluate the Efficacy and Safety of AD-209

April 3, 2024 updated by: Addpharma Inc.

A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AD-209 in Patients With Essential Hypertension

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Condition or disease : hypertension Intervention/treatment Drug : AD-209 Drug : AD-209-1A Drug : AD-209-1B Drug : AD-209-1C Drug : AD-209 Placebo Drug : AD-209-1 Placebo Phase : Phase 2

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 2

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 Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
        • Contact:
          • Chang Gyu Park, 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

19 years to 74 years (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: Experimental 1
AD-209, AD-209-1 placebo
Drug: AD-209
PO, Once daily(QD), 8weeks
Drug: AD-209-1 placebo
PO, Once daily(QD), 8weeks
Experimental: Experimental 2
AD-209-1A, AD-209 placebo
Drug: AD-209-1A
PO, Once daily(QD), 8weeks
Drug: AD-209 placebo
PO, Once daily(QD), 8weeks
Experimental: Experimental 3
AD-209-1B, AD-209 placebo
Drug: AD-209 placebo
PO, Once daily(QD), 8weeks
Drug: AD-209-1B
PO, Once daily(QD), 8weeks
Experimental: Experimental 4
AD-209-1C, AD-209 placebo
Drug: AD-209 placebo
PO, Once daily(QD), 8weeks
Drug: AD-209-1C
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: Chang Gyu Park, M.D., Ph.D, Korea University Guro 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 (Actual)

April 5, 2023

Primary Completion (Actual)

November 27, 2023

Study Completion (Actual)

November 27, 2023

Study Registration Dates

First Submitted

November 20, 2022

First Submitted That Met QC Criteria

November 20, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-209P2-02

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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