Efficacy and Safety of CS-905 (Azelnidipine) in Patients with Essential Hypertension. Early Phase II Clinical Study (Pre-pilot and Pilot I).
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Accession number;99A0676755
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| Title;Efficacy and Safety of CS-905 (Azelnidipine) in Patients with Essential Hypertension. Early Phase II Clinical Study (Pre-pilot and Pilot I). |
| Author;
YOSHINAGA KAORU
(Tohoku Univ.)
IIMURA OSAMU
(Sapporo Med. Coll.)
ABE KEISHI
(Tohoku Univ.)
ISHII MASAO
(Yokohama City Univ.)
SARUTA TAKAO
(Keio Univ.)
OGIHARA TOSHIO
(Osaka Univ.)
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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.15;NO.6;PAGE.869-890(1999)
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| Figure&Table&Reference;FIG.4, TBL.23, REF.17 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;1. Pre-pilot study: In 35 patients with mild to moderate essential hypertension (4 impatients and 31 outpatients), a pre-pilot study was performed to assess the hypotensive effect and safety of CS-905 given once daily at 0.5-8mg/day. 1) Blood pressure showed a significant decrease after treatment for 2 weeks and remained significantly decreased thereafter, constantly. 2) Blood pressure was decreased in 77.1% of the 35 patients, including both impatients and outpatients. The efficacy rate was 14.3%, 28.6%, 48.6%, 74.3%, and 77.1% for final doses of 0.5, .LEQ.1, .LEQ.2, .LEQ.4, and .LEQ.8mg/day, respectively. Consequently, the appropriate initial dose was considered to be 1mg/day. 3) Adverse effects were noted in 6 patients (17.1%), being symptoms in 5 and abnormal laboratory values in 1. The symptoms included facial hot flushes, a feeling of warmth, and a feeling of facial heat, whereas the laboratory abnormalities included elevation of urea nitrogen, uric acid, and GPT. None of these changes were severe. 4) The overall safety was rated as "No safety problems" in 29 (82.9%) of the 35 patients. 5) The usefulness was rated as "Useful" in 27 (77.1%) of the 35 patients. From these results, CS-905 was considered to be effective for mild to moderate essential hypertension, and a dose of 1mg/day or more seems to be clinically appropriate. 2. Pilot study I: A pilot study on CS-905 (1-8mg/day) was performed in 58 outpatients with mild to moderate essential hypertension, in order to assess the hypotensive efficacy and safety.... (author abst.) |
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