경도 또는 중등도의 본태성 고혈압 환자에서 Amlodipine maleate와 AmIodipine besylate의 유효성 및 내약성 비교평가를 위한 8주간의 다기관 공동, 무작위배정, 이중맹검, 이중위약, 대조군 병행 제 3상 임상시험

A 8week, Multi-center, Randomized, Double blinded, Double dummy, Parallel-group Comparative Phase 3 Clinical trial to Assess the Efficacy and Safety of Amlodipine maleate Compared to Amlodipine besylate in Patients with Mild-to-moderate Hypertension

Background & Objectives : Calcium channel blockers(CCB) have been used primary antihyperetensives. among them, second generation CCB, amlodipine besylate(Norvasc), has been used worldwide recent 10years because of it's high bioavailibility and long half life. but, non-besylate amlodipine such as amlodipine maleate has not been used even though it's many biochemical, pharmacological and toxicological information. so, we compared amlodipine besylate with amlodipne maleate in anti-hyperetensive activity and safety. Methods : We used 8weeks, multi-center, randomized, double blinded, double dummy, parallel-group comparative phase 3 clinical trial to assess the efficacy and safety of amlodipine maleate compared to amlodipine besylate in patients with mild-to-moderate hypertension. Results : In anti-hyperertensive efficacy, the mean declines in sDBP was $12.8{\pm}6.5mmHg$ vs $1l.5{\pm}7.3mmHg$ in each cases. difference is 1.2mmHg, and this is meaningless statistically. In safety, there were several side effects such as rash, urticaria, headache, insomnia and so on. But, no severe side effects and statistically meaningful differences were noted in each cases. According to our study, there are little differences between amlodipine besylate and amlodipine maleate in efficacy and safety. Conclusions : Besylate and maleate, are just carriers of amlodipine in the body. amlodipine itself acts on the net anti-hypertensive effect. so, we found that amlodipine besylate and amlodipine maleate show nearly same anti-hypertensive effect and safety regardless of their salt compounds.