A Clinical Pharmacology Study of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea. (NCT04746105) | Clinical Trial Compass
CompletedPhase 1
A Clinical Pharmacology Study of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.
Japan46 participantsStarted 2021-02-24
Plain-language summary
A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.
Who can participate
Age range20 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
What they're measuring
1
Least square mean difference of Apnea hypopnea index (AHI) from placebo