The Optimal Dose of CS-866 (Olmesartan Medoxomil), a novel Angiotensin II Receptor Antagonist, in Patients with Mild-to-moderate Essential Hypertension-Late Phase II Study-
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Accession number;03A0708405
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| Title;The Optimal Dose of CS-866 (Olmesartan Medoxomil), a novel Angiotensin II Receptor Antagonist, in Patients with Mild-to-moderate Essential Hypertension-Late Phase II Study- |
| Author;
ARAKAWA KIKUO
(Fukuoka Univ., Fac. of Med.)
SHIMAMOTO KAZUAKI
(Sapporo Medical Univ., School of Medicine, JPN)
ABE KEISHI
(Tohoku Univ., Sch. of Med.)
SARUTA TAKAO
(Sch. of Med., Keio Univ.)
ISHII MASAO
(Yokohama City Univ., Sch. of Med.)
OGIHARA TOSHIO
(Osaka Univ., Med. Sch.)
HIWADA KUNIO
(Fac. Medicine, Ehime Univ., JPN)
FUJISHIMA MASATOSHI
(Kyushu Univ., Faculty of Medicine, JPN)
FUKIYAMA KOSHIRO
(Fac. Medicine, Univ. Ryukyus, JPN)
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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.9;PAGE.1001-1028(2003)
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| Figure&Table&Reference;FIG.2, TBL.20, REF.12 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;CS-866 5-40mg were orally administered to patients once daily in a successive dose-escalating manner for 12-16 weeks. This late Phase II multicenter open trial was conducted to investigate the efficacy, safety, and optimal dose range of the new angiotensin II receptor antagonist CS-866 (olmesartan medoxomil) for the treatment of mild to moderate essential hypertension. 1) Among 153 patients enrolled, 24 patients were withdrawn or dropped out during the placebo run-in period, and 129 patients proceeded to active treatment period. Of these, 118 completed the trial. The remaining 11 patients comprised 8 cases of discontinuation and 3 cases of withdrawal/dropouts. Six could not complete the trial due to adverse events, and 2 discontinued the trial because of insufficient efficacy. Of the 129 patients who experienced the active treatment, 125 were subjected to analysis, excluding 4 due to violation of inclusion/exclusion criteria. 2) As for the antihypertensive effects, "effective" including "unable to judge" was confirmed in 85.6%, and 89.2%, if "unable to judge" were excluded. The cumulative rates of cases judged as "effective" were 30.4% at 5mg (31.7% if "unable to judge" were excluded), 53.6% up to 10mg (55.8%), 74.4% up to 20mg (77.5%), and 85.6% up to 40mg (89.2%). 3) Blood pressure was normalized at the evaluation point in 73 of the 125 patients. The rate of normalization of blood pressure was 58.4% including "unable to judge", and 60.8% excluding "unable to judge". Blood pressure significantly decreased 2 weeks post initial administration, and remained stable thereafter. 4) Among adverse events seen in 62 patients (49.6%), adverse drug reactions were found in 11 patients (8.8%). Those occurring in two or more patients were dull headache, dizziness, dizziness on standing up, buzzing in the ears, and malaise. 5) Abnormalities in laboratory data were found in 43 patients (34.7%).... (author abst.) |
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