A phase III, multicenter, collaborative, open-label clinical trial of sildenafil in Japanese patients with pulmonary arterial hypertension
スポンサーリンク
概要
- 論文の詳細を見る
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.
- The Japanese Circulation Society = 日本循環器学会の論文
- 2011-02-25
著者
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TAKEHARA Kazuhiko
Department of Dermatology, Kanazawa University Hospital
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YAMADA Norikazu
Department of Cardiology, Mie University Graduate School of Medicine
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Yamada Norikazu
三重大学 医学系研究科循環器内科学
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Yamada Norikazu
Department Of Cardiology Mie University Graduate School Of Medicine
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NAKANISHI Norifumi
Division of Cardiology, National Cardiovascular Center
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Watanabe Hiroshi
Department of Cardiology, Niigata City General Hospital
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Nakanishi Norifumi
The Japanese Society Of Pulmonary Embolism Research
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Tanaka Nobuhiro
Department Of Respirology Graduate School Of Medicine Chiba University
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SATOH Toru
Department of Internal Medicine, School of Medicine, Keio University
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Ogawa Satoshi
Department Of Cardiology Keio University
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Kuriyama Takayuki
Department of Chest Medicine, School of Medicine, Chiba University
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Tanabe Nobuhiro
The Japanese Society Of Pulmonary Embolism Research
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Tanabe Nobuhiro
Department Of Respirology Chiba Graduate School Of Medicine
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Miyaji Katsumasa
Department Of Cardiology National Hospital Organization Okayama Medical Center
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Yao Atsushi
Department of Cardiovascular Medicine, University of Tokyo Graduate School of Medicine
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KURIYAMA Takayuki
School Med. Chiba Univ.
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Kuriyama Takayuki
The Japanese Society of Pulmonary Embolism Research
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Saji Tsutomu
First Department of Pediatrics, Toho University Omori Medical Center
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Suzuki Yumiko
Tokyo Laboratories, Pfizer Global R&D, Pfizer Japan Inc
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Fujiwara Tadami
Tokyo Laboratories, Pfizer Global R&D, Pfizer Japan Inc
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Satoh Tohru
Department Of Cardiology Ashikaga Red Cross Hospital
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Kawata Takayuki
Department Of Respirology Graduate School Of Medicine Chiba University
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Suzuki Yumiko
Tokyo Electric Power Company
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Kuriyama Takayuki
Department Of Respirology Chiba University Graduate School Of Medicine
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Kuriyama Takayuki
Chiba University Graduate Schoolof Medicine
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Takehara Kazuhiko
Department Of Dermatology Kanazawa University
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Satoh Toru
Department Of Cardiology
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Ogawa Satoshi
Department Of Anatomy And Neuroscience Osaka University Medical School
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Kuriyama Takayuki
Department Of Respirology Chiba Graduate School Of Medicine
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Tanabe Nobuhiro
Department Of Chemistry Faculty Of Science Kyoto University
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Kawata Takayuki
Department Of Cardiovascular Science And Medicine Chiba University Graduate School Of Medicine
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Kuriyama Takayuki
Department Of Cardiovascular Science And Medicine Chiba University Graduate School Of Medicine
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Saji Tsutomu
First Department Of Pediatrics Toho University
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Yamada Norikazu
The First Department Of Internal Medicine Mie University School Of Medicine
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Nakano Noritsugu
Department Of Molecular Pathogenesis Division Of Medical Science Medical Research Institute Tokyo Me
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Nakanishi Norifumi
Division Of Cardiology And Ccu National Cerebral And Cardiovascular Center
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Yao Atsushi
Department Of Cardiology Tokyo University Hospital
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Miyaji Katsumasa
Department Of Cardiology Okayama Medical Center
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Takehara Kazuhiko
Department Of Dermatology Kanazawa University Hospital
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Satoh Toru
Department Of Cardiology Kyorin University School Of Medicine
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Suzuki Yumiko
Tokyo Laboratories Pfizer Global R&d Pfizer Japan Inc
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Ogawa Satoshi
Department Of Cardiology Keio University Hospital
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Saji Tsutomu
First Department Of Pediatrics Toho University Omori Medical Center
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Fujiwara Tadami
Tokyo Laboratories Pfizer Global R&d Pfizer Japan Inc
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Watanabe Hiroshi
Department Of Applied Chemistry And Bioengineering Graduate School Of Engineering Osaka City Univers
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Yamada Norikazu
Department Of Cardiology And Nephrology Mie University Graduate School Of Medicine
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Kuriyama Takayasu
Department Of Respirology Chiba Graduate School Of Medicine
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