Trials / Completed
CompletedNCT04905979
Trial of AD113 and Atomoxetine in OSA Patients With Hypertension
Randomized Double-Blind 2-Period Multiple Dose Crossover Study to Evaluate the Efficacy and Safety of AD113 vs Atomoxetine in OSA Patients With Hypertension
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Apnimed · Industry
- Sex
- All
- Age
- 25 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double blind, 2-period, non placebo-controlled crossover study in patients with moderate to severe OSA and controlled hypertension, comparing atomoxetine with AD113
Detailed description
The study is designed to examine the efficacy and safety of AD113 to treat obstructive sleep apnea with hypertension. The study is a two-period multi-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 2 treatments: AD113 for 10 days or Atomoxetine for 10 days. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AD113 | Two oral capsules administered before bed |
| DRUG | Atomoxetine | Two oral capsules administered before bed |
Timeline
- Start date
- 2021-07-31
- Primary completion
- 2023-01-31
- Completion
- 2023-05-31
- First posted
- 2021-05-28
- Last updated
- 2023-08-21
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04905979. Inclusion in this directory is not an endorsement.