Clinical Study of Cinacalcet in Japan
Clinical Study of Cinacalcet in Japan
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DOI：
10.1111/j.1744-9987.2008.00625.x
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发表时间：
2008-10-01
影响因子：
1.9
通讯作者：
Koshikawa, Shozo
中科院分区：
文献类型：
--
作者：
Akizawa, Tadao;Koshikawa, Shozo
为了批准盐酸桂钙，已经进行了五项临床试验，不包括健康志愿者和血液透析患者的药代动力学研究。对于继发性甲状旁腺功能亢进症的常规血液透析患者，开始了一项早期的II期剂量发现研究，从每天12.5毫克金纳多，增加25毫克到50毫克，持续9周。然后进行安慰剂对照的双盲三剂量发现研究(晚期II期研究)。通过这项试验，确定了适当的桂钙素初始剂量为每天25毫克，并使用该初始剂量开始了安慰剂对照的双盲研究(III期研究)。在这些第二阶段和第三阶段研究期间和之后，还进行了两项长期(第一年)第三阶段开放试验。本文总结了两个双盲试验(II期和III期)的结果和在所有日本临床试验中金纳西的安全性概况。
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 hyperparathyroidistn 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 longterm (I 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.