Efficacy and Safety of CS-905 (Azelnidipine) in Patients with Essential Hypertension. Early Phase II Clinical Study (Pilot II).
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Accession number;99A0676756
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| Title;Efficacy and Safety of CS-905 (Azelnidipine) in Patients with Essential Hypertension. Early Phase II Clinical Study (Pilot II). |
| 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.891-905(1999)
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| Figure&Table&Reference;FIG.3, TBL.14, REF.18 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;A dose-finding trial was performed in 45 outpatients with mild to moderate essential hypertension by treating them with 4-16mg of CS-905 once daily for 8-10 weeks to assess the efficacy, safety, and usefulness of the drug. 1) Blood pressure showed a significant decrease after treatment for 2 weeks, and remained decreased constantly thereafter. 2) The blood pressure was rated as "Good" in 77.8%. The efficacy rate was 31.1%, 62.2%, and 77.8% for patients receiving a final dose of 4, .LEQ.8, and .LEQ.16mg/day, respectively. These results showed that 4mg/day is insufficient as the initial dose, so about 8mg/day may be required to start treatment. The efficacy rate was improved when the dose was increased to 16mg/day, therefore, this dose was considered appropriate as the maximum dose. 3) Adverse effects were noted in 2 patients (4.4%), including facial redness and headache. The facial redness initially occurred while the patient was receiving 4mg/day, but persisted until the dose had been increased to 16mg/day. The headache developed early after the initiation of treatment, resulting in discontinuation of the study after 5 days. 4) Abnormal laboratory test values were noted in 2 patients (4.4%). One patient had elevation of total cholesterol and GPT, whereas the other showed a decrease in potassium and elevation of GOT and GPT. 5) The overall safety was rated as "No safety problems" in 84.4%. 6) The usefulness was rated as "Useful" in 75.6%. These results show that CS-905 is useful for the treatment of mild to moderate essential hypertension. The treatment should be started with an initial dose of around 8mg/day and the maximum dose is around 16mg/day. (author abst.) |
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