Clinic blood pressure responses to two amlodipine salt formulations, adipate and besylate, in adult Korean patients with mild to moderate hypertension: A multicenter, randomized, double-blind, parallel-group, 8-week comparison

The commercially available formulation of amlodipine is conjugated with besylate salt to increase water solubility. Recently, a new amlodipine salt formulation has been developed in which the free base of amlodipine is conjugated with a chemically different salt, adipate. The goal of this study was...

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Bibliographic Details
Published in:Clinical therapeutics 2005-06, Vol.27 (6), p.728-739
Main Authors: Lee, Hae-Young, Kang, Hyun-Jae, Koo, Bon-Kwon, Oh, Byung-Hee, Heung-Sun, Kang, Kim, Kee-Sik, Seo, Hong Seog, Ro, Young Moo, Kang, Jin-Ho, Woong, Choi Jae, Joo, Seung-Jae, Kim, Moo Hyun, Joon-Han, Shin, Yoon, Junghan, Park, Seong-Hoon, Jin-Ok, Jeong, Ju, Ahn Kyoung, Chong-Yun, Rhim, Yeon, Kyu Jeong, Park, Kyung Mi, Lim, Dong Kwon, Park, So Youn
Format: Article
Language:English
Subjects:
Adipates - chemistry
Adult
Aged
amlodipine
Amlodipine - adverse effects
Amlodipine - chemistry
Amlodipine - therapeutic use
Angina pectoris
Antihypertensive Agents - adverse effects
Antihypertensive Agents - chemistry
Antihypertensive Agents - therapeutic use
Antihypertensives
Biological and medical sciences
Blood pressure
Blood Pressure - drug effects
Blood Pressure - physiology
calcium channel blocker
Capsules
Double-Blind Method
Drug Administration Schedule
Drug dosages
Female
Flushing - chemically induced
Headache - chemically induced
Heart rate
Humans
Hypertension
Hypertension - drug therapy
Internal medicine
Korea
Male
Medical sciences
Medicine
Middle Aged
Patient Selection
Pharmaceuticals
Pharmacokinetics
Pharmacology. Drug treatments
Pruritus - chemically induced
Time Factors
Treatment Outcome
Uric acid
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Summary:The commercially available formulation of amlodipine is conjugated with besylate salt to increase water solubility. Recently, a new amlodipine salt formulation has been developed in which the free base of amlodipine is conjugated with a chemically different salt, adipate. The goal of this study was to compare the antihypertensive effect and tolerability of amlodipine adipate with those of amlodipine besylate in patients with mild to moderate hypertension. This was a multicenter, randomized, doubleblind, parallel-group study in which patients received 8 weeks of treatment with either amlodipine adipate or amlodipine besylate. The primary efficacy variable was noninferiority of the difference in mean changes from baseline in trough diastolic blood pressure (DBP) after 8 weeks of treatment. Secondary efficacy variables included mean changes in DBP, systolic blood pressure (SBP), and response rate (defined as the proportion of patients whose DBP was
ISSN:0149-2918
1879-114X
DOI:10.1016/j.clinthera.2005.06.011