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
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