Phase III Study to Evaluate the Efficacy and Safety of AD-209

NCT06348576 ↗

Phase 3 Unknown 280 enrolled Addpharma Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2024-05-20
Primary completion: 2025-02
Completion: 2025-02

Outcome

Met primary endpoint

paper Furthermore, the superiority of the combination therapy was confirmed in the full analysis set (LS mean difference, -4.0 mm Hg [95% CI, -6.8 to -1.3]; P<0.01). PMID 41717679 ↗

paper At week 8, the combination group demonstrated significant mean sitting systolic blood pressure reduction compared with monotherapy in the per-protocol set analysis PMID 41717679 ↗

Publications

Ahn JC, Lee CW, Ahn JH, Lim KH, Sohn IS, Sung KC, Kim KH, Bae JH, Hong SP, Jang WY, Jo SH, Han SH, Kim JB, Lee CJ, Lee JH, Kim N, Cho EJ, Sung JH, Ahn HS, Kim SY, Shin J, Seo SM, Hong SJ, Kim W, Park CG. Low-Dose TEL/AML/CHTD SPC Versus Standard-Dose TEL in Hypertension: Phase III RCT. Hypertension. 2026 Apr;83(4):e25810. doi: 10.1161/HYPERTENSIONAHA.125.25810. Epub 2026 Feb 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	2.5 mg	Oral
Subject	Chlorthalidone	Other / unclassified	6.25 mg	Oral
Comparator	Telmisartan	Other / unclassified	20 mg	Oral
Comparator	Telmisartan	Other / unclassified	40 mg	Oral