Abstract:

Objective   To evaluate the efficacy and safety of manidipine hydrochloride among patients with essential mild or moderate hypertension. Methods   Two hundred and forty subjects with mild or moderate hypertension were enrolled in the study and assigned to two groups (the study group and the control group) equally by a randomized, double-blind，multicenter and positive controlled study．After a one to two-week placebo run-in period， patients with essential mild or moderate hypertension were distributed randomly into two groups to receive study drug (manidipine hydrochloride 10～20mg per day) or positive controlled drug ( amlodipine besylate 5～10mg per day) respectively for 8 weeks. BP change, tolerance and adverse events between the two groups were evaluated． Results   One hundred and three patients completed trial in the study group and 103 patients in the control group．Subjects who completed the study were with good compliance，except those dropped off or were excluded．There was no significant difference for baseline characteristics between the two groups (P＞0.05) including age，sex，body mass index，baseline systolic and diastolic BP，and heart rate．The reduction of diastolic and systolic BP, heart rate and seat diastolic blood pressure normalized rate between the two groups had no significant difference at the end of treatment (P>0.05). The incidence of adverse events also had no significant difference between the two groups(P＞0.05). Conclusion   The antihypertensive efficacy of manidipine hydrochloride is equal to amlodipine besylate among patients with mild or moderate hypertension. Manidipine hydrochloride is safe and can be well tolerated．

Key words: Manidipine hydrochloride; Amlodipine besylate; Essential hypertension