Trials / Completed
CompletedNCT04445688
Crossover Trial of AD036 in Obstructive Sleep Apnea
Phase 2, Randomized, 3-Period, Placebo-Controlled Crossover Study to Evaluate the Efficacy and Safety in Obstructive Sleep Apnea of AD036 Versus Placebo or Atomoxetine
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Apnimed · Industry
- Sex
- All
- Age
- 25 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.
Detailed description
The study is designed to examine the efficacy and safety of AD036 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight Home Sleep Apnea Testing (HSAT) with dosing of one of the following 3 treatments: AD036, Atomoxetine, or Placebo. Participants will return 1 week after their final crossover HSAT for an end of study (EOS) Visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AD036 | Oral administration before bed |
| DRUG | Atomoxetine | Oral administration before bed |
| DRUG | Placebo | Oral administration before bed |
Timeline
- Start date
- 2020-07-15
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2020-06-24
- Last updated
- 2023-09-14
- Results posted
- 2023-08-21
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04445688. Inclusion in this directory is not an endorsement.