A clinical pharmacology study of TS-142 in patients with obstructive sleep apnea hypopnea.
Completed
- Conditions
- Obstructive sleep apnea hypopnea
- Registration Number
- jRCT2031200373
- Lead Sponsor
- Taisho Pharmaceutical Co., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Subjects must meet all of the following criteria to be included in this study:
- Japanese male and female, age 20 years or older at the time of informed consent
- Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for obstructive sleep apnea hypopnea
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
- Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting obstructive sleep apnea hypopnea and insomnia disorder
- Patients who have clinically significant respiratory dysfunction (bronchiectasis, emphysema, asthma, etc.) other than obstructive sleep apnea hypopnea
- Patients with percutaneous arterial oxygen saturation (SpO2) <94% by pulse oximetry at visit 1
- Other protocol defined exclusion criteria could apply
Study & Design
- Study Type
- Interventional
- Study Design
- crossover assignment
- Primary Outcome Measures
Name Time Method - Apnea hypopnea index
- Secondary Outcome Measures
Name Time Method