Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AD109 75
AD109 dose1- A · 1 trial · 1 indication
Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%\[% min/h\]. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.
Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.
| Arm | Type | Description |
|---|---|---|
| Sequence ABC | OTHER | AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C). |
| Sequence ACB | OTHER | AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B) |
| Sequence BAC | OTHER | AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C) |
| Sequence BCA | OTHER | AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A) |
| Sequence CAB | OTHER | Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B) |
| Sequence CBA | OTHER | Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A) |
| Name | Type | Description |
|---|---|---|
| AD109 dose1- A | DRUG | Oral administration at bedtime |
| AD109 dose2- B | DRUG | Oral administration at bedtime |
| Placebo- C | DRUG | Oral administration at bedtime |
Inclusion Criteria: * AHI between 5 and 20 events/h * PGI-S equal to or higher than 1, or one or more of the following symptoms: * Snoring or nightime gasping/choking * Daytime sleepiness, fatigue or decreased concentration * Nonrefreshing sleep, sleep fragmentation (including from nocturia)...