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A phase III, multicenter, collaborative, open-label clinical trial of sildenafil in Japanese patients with pulmonary arterial hypertension
http://hdl.handle.net/2297/27105
http://hdl.handle.net/2297/27105abd6fc3d-d033-487f-9b83-99c5db270c03
名前 / ファイル | ライセンス | アクション |
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ME-PR-TAKEHARA-K-677.pdf (237.1 kB)
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Item type | 学術雑誌論文 / Journal Article(1) | |||||
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公開日 | 2017-10-03 | |||||
タイトル | ||||||
タイトル | A phase III, multicenter, collaborative, open-label clinical trial of sildenafil in Japanese patients with pulmonary arterial hypertension | |||||
言語 | ||||||
言語 | eng | |||||
資源タイプ | ||||||
資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
資源タイプ | journal article | |||||
著者 |
Satoh, Tohru
× Satoh, Tohru× Saji, Tsutomu× Watanabe, Hiroshi× Ogawa, Satoshi× Takehara, Kazuhiko× Tanabe, Nobuhiro× Yamada, Norikazu× Yao, Atsushi× Miyaji, Katsumasa× Nakanishi, Norifumi× Suzuki, Yumiko× Fujiwara, Tadami× Kuriyama, Takayuki |
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提供者所属 | ||||||
内容記述タイプ | Other | |||||
内容記述 | 金沢大学医薬保健研究域医学系 | |||||
書誌情報 |
Circulation Journal 巻 75, 号 3, p. 677-682, 発行日 2011-01-01 |
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ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 1346-9843 | |||||
NCID | ||||||
収録物識別子タイプ | NCID | |||||
収録物識別子 | AA11591968 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.1253/circj.CJ-10-0671 | |||||
出版者 | ||||||
出版者 | The Japanese Circulation Society = 日本循環器学会 | |||||
抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Background: There is evidence that phosphodiesterase type-5 is effective for the treatment of pulmonary arterial hypertension (PAH). Methods and Results: A phase III, multicenter, open-label clinical trial of sildenafil 20 mg t.i.d. was conducted in 21 Japanese patients with PAH to examine its efficacy, safety, and pharmacokinetics. The present trial consisted of a screening period and 12-week treatment. Patients who were enrolled in the present trial increased their 6-min walking distance of administration increased at week 12 by 84.2 m from baseline. Hemodynamic parameters (eg, mean pulmonary artery pressure and pulmonary vascular resistance), Borg dyspnea scores, and plasma brain natriuretic peptide concentrations also improved compared to baseline. Most patients improved or sustained WHO functional class. Seven subjects, who were examined for the pharmacokinetics of sildefanil, showed relatively large interindividual variations in the Cmax, AUC0-8, Css,av, and Ctrough of the drug. Any serious adverse events, severe adverse events, and deaths were not observed. Most of events of undeniable causality were mild or moderate in severity. Sildefanil was well tolerated by the subjects. Conclusions: Sildenafil 20 mg t.i.d. was effective and safe for Japanese patients with PAH. | |||||
権利 | ||||||
権利情報 | Copyright (c) 2011 THE JAPANESE CIRCULATION SOCIETY | |||||
著者版フラグ | ||||||
出版タイプ | VoR | |||||
出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
関連URI | ||||||
識別子タイプ | URI | |||||
関連識別子 | http://www.jstage.jst.go.jp/article/circj/75/3/75_677/_article |