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

February 2, 2025 updated by: Addpharma Inc.

A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AD-227A and AD-227B Combination Treatment in Patients with Essential Hypertension

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Essential Hypertension

Study Type

Interventional

Enrollment (Estimated)

251

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 Locations

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: Co-administration of AD-227A and AD-227B
AD-227A + AD-227B + Placebo of AD-227C
Drug: AD-227A
Per Oral, 1 Tablet, Once a day for 8 weeks
Drug: AD-227B
Per Oral, 1 Tablet, Once a day for 8 weeks
Drug: Placebo of AD-227C
Per Oral, 1 Tablet, Once a day for 8 weeks
Active Comparator: AD-227A
AD-227A + Placebo of AD-227B + Placebo of AD-227C
Drug: AD-227A
Per Oral, 1 Tablet, Once a day for 8 weeks
Drug: Placebo of AD-227C
Per Oral, 1 Tablet, Once a day for 8 weeks
Drug: Placebo of AD-227B
Per Oral, 1 Tablet, Once a day for 8 weeks
Active Comparator: Co-administration of AD-227A and AD-227C
AD-227A + Placebo of AD-227B + AD-227C
Drug: AD-227A
Per Oral, 1 Tablet, Once a day for 8 weeks
Drug: Placebo of AD-227B
Per Oral, 1 Tablet, Once a day for 8 weeks
Drug: AD-227C
Per Oral, 1 Tablet, Once a day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in MSSBP
Time Frame: Baseline to Week8
Change from Baseline in Mean Sitting Systolic Blood Pressure
Baseline to Week8

Collaborators and Investigators

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

Sponsor

Addpharma Inc.

Investigators

  • Principal Investigator: Chong-Jin Kim, Gangnam CHA Medical Center

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)

July 31, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 2, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-227P3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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