Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AD036 Dose 1
AD036 · 2 trials · 1 indication
Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo
Number of participants with ≥50% reduction in apnea hypopnea index (AHI). AHI is the average number of apneas and hypopneas a person experiences each hour during sleep, to register as an event an apnea or hypopnea must last at least 10 seconds or longer. To measure this, doctors divide the total number of apneic and hypopneic events by the total number of hours the person was asleep.
| Arm | Type | Description |
|---|---|---|
| AD036 | EXPERIMENTAL | AD036 oral capsule administered before sleep |
| Atomoxetine | ACTIVE_COMPARATOR | Atomoxetine oral capsule administered before sleep |
| Placebo | PLACEBO_COMPARATOR | Placebo oral capsule administered before sleep |
| 2-Night at Home | PLACEBO_COMPARATOR | An initial 2-night, at-home blinded baseline period in which all subjects received placebo |
| 3-Night Run In | EXPERIMENTAL | AD036 Dose 1 (Low Dose: 25/5) or Placebo |
| 7-Night | EXPERIMENTAL | A 7-night treatment period in which subjects received the treatment to which they were randomized, i.e., 1 of the 3 different fixed-dose combinations of drugs, or placebo |
| End of Study | NO_INTERVENTION | End of Study Visit |
| Name | Type | Description |
|---|---|---|
| AD036 | DRUG | Oral administration before bed |
| Atomoxetine | DRUG | Oral administration before bed |
| Placebo | DRUG | Oral administration before bed |
| AD036 Dose 1 | DRUG | AD036 Dose 1 oral capsule administered before sleep |
| AD036 Dose 2 | DRUG | AD036 Dose 2 oral capsule administered before sleep |
| AD036 Dose 3 | DRUG | AD036 Dose 3 oral capsule administered before sleep |
Inclusion Criteria: * Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit. * AHI 10 to \<20, or AHI ≥20 if meets PSG criteria Exclusion Criteria: * History of narcolepsy. * Clinically significant craniofacial malformation. * Clinically significant cardiac disease (e.g...