Status:
COMPLETED
A Clinical Pharmacology Study of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.
Lead Sponsor:
Taisho Pharmaceutical Co., Ltd.
Conditions:
Patients with Mild Obstructive Sleep Apnea Hypopnea
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2021
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04746105
Start Date
February 24 2021
End Date
October 30 2021
Last Update
February 28 2025
Active Locations (1)
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1
Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan