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Accession number;04A0046811
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| Title;Investigation of Relationship between Pharmacokinetics and Antihypertensive Effect of CS-866 (Olmesartan Medoxomil) in Mild to Moderate Essential Hypertensive Patients |
| Author;
NAKAJIMA MITSUYOSHI
(Hamamatsucptken)
TANAKA TAKANORI
(Aioikai Osakikurinikku)
OSAKA ATSUMI
(Arisukai Kyomachinaikabyoin)
KANADA SHIGETO
(Osaka Pharmacol. Res. Clin.)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.19;NO.12;PAGE.1397-1420(2003)
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| Figure&Table&Reference;FIG.13, TBL.14, REF.13 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;CS-866 (Olmesartan medoxomil) is an orally active angiotensin II receptor antagonist and an antihypertensive agent. It is converted to an active metabolite, RNH-6270, after oral administration. Relationship between pharmacokinetics and antihypertensive effect of CS-866 was investigated in the double-blind, placebo-controlled, parallel-group comparative study. CS-866 at doses of 10mg, 20mg or placebo was orally administrated to 56 patients with mild to moderate essential hypertension once daily for 14 consecutive days. The area under the plasma concentration versus time curve (AUC0-24) and the maximum plasma concentration (Cmax) of RNH-6270 increased in a dose-dependent manner. The plasma concentration profile of RNH-6270 shown in this study was similar to that shown in healthy volunteers in previous studies. CS-866 at both doses showed significant antihypertensive effect compared to placebo. The relationship between AUC0-24 of RNH-6270 and antihypertensive effect was well described with a linear model, and it was shown that the effect increased linearly with an increase in AUC0-24. Concerning safety, no clinically significant abnormalities were confirmed and it was concluded that CS-866 was well tolerated and safe in this study. (author abst.) |
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