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

• Sponsor: Addpharma Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06052748
• Collaborator: (none)
• Enrollment: 486
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 16.1
• Patients Per Site Per Month: 30.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension,Essential	Drug: AD-223A; Drug: AD-223B; Drug: AD-223C; Drug: AD-223A Placebo; Drug: AD-223B Placebo; Drug: AD-223C Placebo	Phase 3

Detailed Description

Condition or disease : hypertension

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 486 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2025
• Anticipated Study Completion Date: Feb 1, 2025

Arms and Interventions

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-223B Placebo; PO, Once daily(QD), 8weeks; Drug: AD-223C 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-223A Placebo; PO, Once daily(QD), 8weeks; Drug: AD-223C Placebo; PO, Once daily(QD), 8weeks
Active Comparator: Control group 3 AD-223A Placebo+AD-223B Placebo+AD-223C	Drug: AD-223C; PO, Once daily(QD), 8weeks; Drug: AD-223A Placebo; PO, Once daily(QD), 8weeks; Drug: AD-223B Placebo; PO, Once daily(QD), 8weeks

Outcome Measures

Primary Outcome Measures

1. Change rate of MSSBP [Baseline, Week 8]

   Change from baseline in mean sitting systolic blood pressure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed informed consent

• Other inclusions applied

Exclusion Criteria:

• Orthostatic hypotension with symptom

• Other exclusions applied

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanyang University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Addpharma Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Addpharma Inc.
• ClinicalTrials.gov Identifier: NCT06052748
• Other Study ID Numbers: AD-223P3
• First Posted: Sep 25, 2023
• Last Update Posted: Sep 25, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension; Essential Hypertension

Study Results

No Results Posted as of Sep 25, 2023