jRCT2031200143已完成不适用
A long-term extension study of HP-5070 in patients with primary hyperhidrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 12age old over 至 No limit（—）
- 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.)
结局指标
主要结局
-
Adverse events
次要结局
未报告次要终点
研究者
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