title: Clinical study of cinacalcet in Japan.
abstract: For the approval of cinacalcet hydrochloride, five clinical trials have been performed excluding pharmacokinetic studies for healthy volunteers and hemodialysis patients. An early phase II dose-finding study was started for regular hemodialysis patients with secondary hyperparathyroidism from a daily dose of 12.5 mg cinacalcet and increasing 25 mg up to 50 mg for 9 weeks. A placebo-controlled double-blind three dose-finding study (late phase II study) was then conducted. By this trial, an adequate initial dose of cinacalcet was determined as 25 mg daily, and the placebo-controlled double-blind study (phase III study) was started using this initial dose. Two long-term (1 year) phase III open trials were also conducted during and after these phase II and III studies. The results of two double-blind trials (phase II and phase III) and safety profiles of cinacalcet in all Japanese clinical trials for approval are summarized in this article.
authors.affiliation: Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan. akizawa@med.showa-u.ac.jp
authors.forename: Tadao
authors.initials: T
authors.lastname: Akizawa
authors.forename: Shozo
authors.initials: S
authors.lastname: Koshikawa
mesh_terms: D044466:Asian People; D000069449:Cinacalcet; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy* / Q000209:etiology; D007564:Japan; D008137:Longitudinal Studies; D009281:Naphthalenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006435:Renal Dialysis
chemical_list: D009281:Naphthalenes; D000069449:Cinacalcet