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

NCT06052748 ↗

Phase 3 Completed 502 enrolled Addpharma Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2024-02-15
Primary completion: 2025-03-27
Completion: 2025-04-02

Outcome

Met primary endpoint

paper At week 8, TEL/AML 20/2.5 showed significantly greater MSSBP reductions compared with TEL 20 [least squares mean (LSM) differences: -5.79 mmHg; p = 0.0003] PMID 42130156 ↗

paper Non-inferiority to TEL 40 was established, with an LSM difference of -3.88 mmHg (95% Confidence Interval: -6.67 to -1.09) PMID 42130156 ↗

Publications

Ahn HS, Ahn JC, Cho JM, Lim KH, Han SH, Cho YK, Kim KH, Hong SJ, Lee CJ, Na JO, Sung KC, Choi K, Kim SY, Kim DH, Lee HC, Ihm SH, Youn JC, Choi JY, Kim SH, Kim KI, Sung JH, Pyun WB, Kim WS, Cho JS, Lee Y, Her SH, Cho EJ, Lee EM, Lee HY, Yoon YW, Lee JH, Kim W, Rhee SJ, Shin J. Low-Dose Telmisartan/Amlodipine in Essential Hypertension: A Phase III Trial. J Clin Hypertens (Greenwich). 2026 May;28(5):e70279. doi: 10.1111/jch.70279.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	2.5 mg	Oral
Comparator	Telmisartan	Other / unclassified	20 mg	Oral
Comparator	Telmisartan	Other / unclassified	40 mg	Oral