drugset / Trial / NCT04449133
Study of AD128 Versus Placebo in Obstructive Sleep Apnea
Phase 2
Completed
20 enrolled
Istituto Auxologico Italiano
Apnimed · collabSTM Pharma PRO srl · collabYGHEA, CRO Division of Ecol Studio spa · collab
RandomizedCrossoverQuadruple-blindTreatment
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.
Timeline
- Start
- 2020-07-03
- Primary completion
- 2020-10-30
- Completion
- 2020-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxybutynin | Small molecule | 5 mg | Oral |
| Subject | Reboxetine | Unknown | 4 mg | Oral |