Objective: To compare the antihypertensive effect and safety of lacidipine and amlodipine among middle-aged and elderly Chinese patients with mild-to-moderate hypertension. Methods: This is a multicenter, randomized, double-blind, double dummy, parallel positive controlled clinical trial in which patients received 2 weeks of treatment with either lacidipine or amlodipine. Patients aged 50 to 80 years old with mild-to-moderate primary hypertension were randomizedly assigned to receive lacidipine 4~6 mg per day with amlodipine stimulant or amlodipine 5~7.5 mg per day with lacidipine stimulant after 2-week placebo cleaning. The sitting blood pressures were measured at the 0, 2, 4, 8, 12, 16 and 20th weeks. The 24 hours ambulatory blood pressure monitorings were performed prior to and after treatment. Results: A total of 263 patients were included in the intent-to-treat analysis and randomly assigned to receive lacidipine (n=132) or amlodipine besylate (n=131). There were no differences among baseline characteristics between the two groups. The mean (SD) SBP and pulse pressure changes at 20 weeks were respectively (24.7±11.4) and (10.3±9.8) mmHg in the lacidipine group and (24.2±10.5) and (9.7±9.2) mmHg in the amlodipine group (P>0.05). There were no differences in mean diastolic blood pressure (DBP) changes, control rate, blood pressure variability, trough:peak ratio, smoothness index and adverse events between the two groups, whereas only amlodipine group presented two cases with stroke and three cases with gingival hyperplasia (P>0.05). Conclusions: Lacidipine treatment smoothly reduced blood pressure in middle-aged and elderly Chinese patients with mild-to-moderate hypertension. The efficacy and tolerability of lacidipine are comparable with amlodipine. © 2019, Chinese Journal of New Drugs Co. Ltd. All right reserved.