Trials / Completed
CompletedNCT04449133
Study of AD128 Versus Placebo in Obstructive Sleep Apnea
Crossover, Double-blind, Phase 2 Study of AD128 Versus Placebo in Obstructive Sleep Apnea
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Istituto Auxologico Italiano · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Obstructive Sleep Apnea (OSA) is the most common and serious of the sleep disorders. Long-term, OSA is associated with increased morbidity and mortality, with a number of adverse cardiovascular, neurocognitive, metabolic, and daytime functioning consequences. No drugs are currently approved for OSA treatment. This is a randomized, double blind, placebo controlled, cross-over, inpatient phase 2 clinical trial to examine the efficacy and the safety of a fixed dose level of AD128 in patients with OSA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AD128 | Oral administration of two capsules before sleep for 7 days. |
| DRUG | Placebo | Oral administration of two capsules before sleep for 7 days. |
Timeline
- Start date
- 2020-07-03
- Primary completion
- 2020-10-30
- Completion
- 2020-10-31
- First posted
- 2020-06-26
- Last updated
- 2021-09-27
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04449133. Inclusion in this directory is not an endorsement.