A long-term extension study of HP-5070 in patients with primary hyperhidrosis
- Conditions
- Primary local hyperhidrosis
- Registration Number
- JPRN-jRCT2031200143
- Lead Sponsor
- Customer Service Office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 120
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
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.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events
- Secondary Outcome Measures
Name Time Method The proportion of responders with the defined volume of sweat