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

Phase 3

Completed

• Conditions: Hypertension,Essential
• Interventions: Drug: AD-223A; Drug: AD-223C; Drug: AD-223B; Drug: AD-223B Placebo; Drug: AD-223A Placebo; Drug: AD-223C Placebo

• Registration Number: NCT06052748
• Lead Sponsor: Addpharma Inc.

Brief Summary

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

Detailed Description

Condition or disease : hypertension

Study Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-25
• Study Start: 2024-02-15
• Primary Completion: 2025-03-27
• Status Verified: 2025-04
• Study Completion: 2025-04-02
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

• Signed informed consent
• Other inclusions applied

Exclusion Criteria

• Orthostatic hypotension with symptom
• Other exclusions applied

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	AD-223A	AD-223A+AD-223B+AD-223C Placebo
Test group	AD-223B	AD-223A+AD-223B+AD-223C Placebo
Test group	AD-223C Placebo	AD-223A+AD-223B+AD-223C Placebo
Control group 1	AD-223A	AD-223A+AD-223B Placebo+AD-223C Placebo
Control group 1	AD-223B Placebo	AD-223A+AD-223B Placebo+AD-223C Placebo
Control group 1	AD-223C Placebo	AD-223A+AD-223B Placebo+AD-223C Placebo
Control group 2	AD-223B	AD-223A Placebo+AD-223B+AD-223C Placebo
Control group 2	AD-223A Placebo	AD-223A Placebo+AD-223B+AD-223C Placebo
Control group 2	AD-223C Placebo	AD-223A Placebo+AD-223B+AD-223C Placebo
Control group 3	AD-223A Placebo	AD-223A Placebo+AD-223B Placebo+AD-223C
Control group 3	AD-223B Placebo	AD-223A Placebo+AD-223B Placebo+AD-223C
Control group 3	AD-223C	AD-223A Placebo+AD-223B Placebo+AD-223C

Primary Outcome Measures

Name	Time	Method
Change rate of MSSBP	Baseline, Week 8	Change from baseline in mean sitting systolic blood pressure

Trial Locations

Locations (1)

Hanyang University Hospital; 🇰🇷 Seoul, Korea, Republic of