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Shin, Chung, Seo, Yang, Park, Kim, and On: Efficacy and Safety of Amlodipine Camsylate(Amodipin(TM)) for Treatment of Essential Hypertension
Original Article
Randomized Controlled Trial
Multicenter Study
Korean Circulation Journal

Korean Circulation Journal 2005; 35(3): 247-252.

Published online: 31 March 2005

DOI: https://doi.org/10.4070/kcj.2005.35.3.247

Efficacy and Safety of Amlodipine Camsylate(Amodipin(TM)) for Treatment of Essential Hypertension

Eak Kyun Shin, Wook Sung Chung, Hong Seok Seo, Ju Young Yang, Jung Bae Park, Jae Joong Kim, Young Keun On

Division of Cardiology, Gil Medical Center, Gachon Medical School, Incheon, Korea.

Division of Cardiology, Yeoeuido St. Mary's Hospital, College of Medicine, The Catholic University, Seoul, Korea.

Division of Cardiology, Korea University College of Medicine, Guro Hospital, Seoul, Korea.

Division of Cardiology, Nation Health Insurance Corporation Ilsan Hospital, Ilsan, Korea.

Division of Cardiology, College of Medicine, University of Sungkyunkwan, Seoul, Korea.

Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Division of Cardiology, College of Medicine, Soonchunhyang University, Seoul, Korea.

ekshin@ghil.com

Copyright © 2005 The Korean Society of Circulation

Abstract

BACKGROUND AND OBJECTIVES: Amlodipine camsylate (Amodipin(TM)), a newly developed amlodipine formulation, has similar physical properties and pharmacokinetic equivalency to that of the conventional formulation (amlodipine besylate, Norvasc(R)).
SUBJECTS AND METHODS: This prospective, randomized, double-blind, parallel designed, multicenter study was conducted at a total of 7 sites. 95 patients with mild to moderate essential hypertension were enrolled. Following the 2 week administration of a placebo, the patients received 5 mg of amlodipine once a day for a total of 8 weeks. If either the blood pressure was > or =140/90 mmHg or the sitting diastolic blood pressure had not decreased by > or =10 mmHg from those at the baseline after 4 weeks of treatment, the dose of amlodipine was increased to 10 mg. The blood pressure was measured twice every 4 weeks and mean value recorded.
RESULTS: The diastolic and systolic blood pressures were significantly decreased with both amlodipine camsylate (baseline DBP: 97.4±5.8 mmHg, 8th week DBP: 84.1±8.8 mmHg, mean differences: -13.3±7.4) and amlodipine besylate (baseline DBP: 95.9±5.9 mmHg, 8th week DBP: 83.2±9.2 mmHg, mean differences: -12.4±8.3). The incidence of drug related adverse events was similar in both groups.
CONCLUSION: This study suggests that once-a-day monotherapy of amlodipine camsylate is effective for the control of blood pressure in patients with essential hypertension, without significant adverse events.

Keywords: Antihypertensive agents, Calcium channel blockers, Blood pressure

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