Soonchunhyang University Hospital

A multicenter, randomized, double-blind study evaluated the antihypertensive efficacy and safety of AML plus CC versus AML monotherapy in Korean patients with uncontrolled essential hypertension. Patients underwent a 4-week AML monotherapy run-in period, followed by randomization to combination therapy or AML monotherapy for 8 weeks. The primary outcome was DBP change at week 8, with additional assessments at weeks 4, 12, and 16. Safety was monitored through adverse events. The study aimed for KMFDS approval for the AML/CC fixed-dose combination.