Late Phase II Study of CS-905, Azelnidipine, in Patients with Essential Hypertension. A Multi-center, Double-blind Comparative Study for Evaluation of Optimal Dose.
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Accession number;99A0676757
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| Title;Late Phase II Study of CS-905, Azelnidipine, in Patients with Essential Hypertension. A Multi-center, Double-blind Comparative Study for Evaluation of Optimal Dose. |
| Author;
YOSHINAGA KAORU
(Tohoku Univ., Sch. of Med.)
IIMURA OSAMU
(Sapporo Med. Coll.)
SARUTA TAKAO
(Keio Univ.)
KUROKAWA KIYOSHI
(Univ. of Tokyo, Fac. of Med.)
ISHII MASAO
(Yokohama City Univ., Sch. of Med.)
TAKEDA RYOYU
(Sch. of Med., Kanazawa Univ.)
TOYAMA JUNJI
(Nagoya Univ.)
OGIHARA TOSHIO
(Osaka Univ.)
OHASHI YASUO
(Univ. of Tokyo, Grad. Sch.)
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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.907-942(1999)
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| Figure&Table&Reference;FIG.4, TBL.32, REF.24 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Patients with mild to moderate essential hypertension were divided into two groups receiving azelnidipine at low doses of 6-12mg (Group L, n=110) and high doses of 8-16mg (Group H, n=112), and a double-blind clinical trial was conducted to evaluate azelnidipine at 8 to 16mg once daily for effectiveness, safety, and usefulness. 1) After treatment for 8-10 weeks at the final dose, a hypotensive effect was recognized in 68.2% of all patients and 71.4% of evaluable patients (excluding unevaluable cases) from Group L, and in 75.0% and 77.8% from Group H, respectively. The rates for Group H were higher than the corresponding rates for Group L, but there was no significant difference between the two groups. 2) Blood pressure decreased significantly after two weeks in each group and then gradually decreased further. The two curves were not significantly different at any time at which blood pressure was measured. 3) Heart rate in the treatment period did not show any increase from baseline in both groups, while significant decrease was recognized after 10 weeks in Group H. With respect to the difference of the treatment period from the baseline, heart rate did not change in Group L and tended to decrease in Group H. It was concluded that CS-905 did not affect the heart rate at any dose, and considered to be preferable in Group H. 4) Adverse effects occurred in 10.9% (12/110) and 12.5% (14/112) of patients from Groups L and H, respectively. The rate for Group L was lower than that for Group H, but the difference was not significant. Symptoms such as hot flushes, palpitations, dizziness on standing up, and generalized itching occurred in 1.7% and 2.6% of patients from Groups L and H, respectively, but all of these symptoms were mild or moderate. Abnormal laboratory test values such as elevation of GOT and GPT occurred in 9.1% and 9.8% of Groups L and H, respectively.... (author abst.) |
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