@article{oai:kanazawa-u.repo.nii.ac.jp:00013362,
 author = {Satoh, Tohru and Saji, Tsutomu and Watanabe, Hiroshi and Ogawa, Satoshi and Takehara, Kazuhiko and Tanabe, Nobuhiro and Yamada, Norikazu and Yao, Atsushi and Miyaji, Katsumasa and Nakanishi, Norifumi and Suzuki, Yumiko and Fujiwara, Tadami and Kuriyama, Takayuki},
 issue = {3},
 journal = {Circulation Journal},
 month = {Jan},
 note = {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., 金沢大学医薬保健研究域医学系},
 pages = {677--682},
 title = {A phase III, multicenter, collaborative, open-label clinical trial of sildenafil in Japanese patients with pulmonary arterial hypertension},
 volume = {75},
 year = {2011}
}