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临床试验/JPRN-jRCT2031200143
JPRN-jRCT2031200143已完成3 期

A long-term extension study of HP-5070 in patients with primary hyperhidrosis

Customer Service Office0 个研究点目标入组 120 人开始时间: 2020年10月9日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
120

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 12age old 至 ot applicable(—)
性别
All

入选标准

  • Patients who continued into the extension
  • - Japanese patients with primary local hyperhidrosis who completed the prior study
  • - Patients wishing to continue to receive HP-5070 after participating in the prior study
  • New patients
  • - Japanese patients aged 12 years or older
  • - Patients with a diagnosis of primary local hyperhidrosis
  • - Patients with involvement of palmar sites

排除标准

  • Patients who continued into the extension
  • - Patients with a resting pulse rate of less than 45 beats per minute or more than 90 beats per minute measured during the pre-observation period of the prior study
  • - Patients with a QTcF of 450 msec or more on a 12-lead ECG measured during the pre-observation period of the prior study
  • - Patients with abnormal waveforms on a 12-lead ECG measured during the pre-observation period of the prior study
  • New patients
  • - Patients with secondary hyperhidrosis
  • - Patients with heavy sweating due to climacteric disturbance
  • - Patients who have undergone surgery for hyperhidrosis (sympathectomy, nerve block, laser surgery, etc.)

研究者

发起方
Customer Service Office

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