|
KMID : 0391020050130010064
|
|
Journal of Korean Society for Clinical Pharmacology and Therapeutics
2005 Volume.13 No. 1 p.64 ~ p.83
|
|
|
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
|
|
Lee Hyoung-Don
Kim Seok-Yeon
Han Bong-Jun
Kang Hyun-Min
Park Jae-Eun
Kang Jin-Ho
Kim Bum-Soo
Sung Ki-Chul
Kim Byung-Jin
Kim Jin-Woo
Hur Seung-Ho
Kim Ki-Sik
Lee In-Kyu
Kim Hey-Soon
Kim Mi-Jung
Kim Chul-Min
|
|
|
Abstract
|
|
|
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.
|
|
|
KEYWORD
|
|
|
|
|
|
FullTexts / Linksout information
|
|
|
|
|
Listed journal information
|
|
 
|
|