Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TS-142 | Experimental | Period in which subjects received TS-142 10 mg or The night when subjects received TS-142 |
|
| Placebo | Experimental | Period in which subjects received placebo or The night when subjects received matched placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-142 | Drug | Subjects received single-dose of 10 mg of TS-142 (oral tablet) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Least square mean difference of Apnea hypopnea index (AHI) from placebo | AHI is a number of apnea and hypopnea events per hour during sleep determined by polyso㎜ography (PSG). | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Least square mean difference of the mean SpO2 in total sleep time from placebo | The SpO2 will be simultaneously measured with PSG. The mean SpO2 during sleep determined by PSG will be calculated. | Day 1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Taisho Direcoter | Taisho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taisho Pharmaceutical Co., Ltd selected site | Tokyo | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000723815 | TS-142 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dose-matched Placebo to TS-142 |
| Drug |
Subjects received single-dose matched placebo to TS-142 (oral tablet) |
|