CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
AD109 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04580394
NCT04580394Phase 2Completed
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Phase 2 Randomized Double-Blind Placebo-Controlled 4-Period Single-Dose Crossover Factorial Study to Evaluate the Contribution of the Individual Drug Components to the Efficacy of AD109 in Obstructive Sleep Apnea

Apnimed·interventional·Posted Oct 8, 2020·Updated Jan 31, 2023

In Brief

A Phase 2 clinical trial evaluating AD109, Atomoxetine, and 3 other interventions for Obstructive Sleep Apnea. Completed, enrolled 60 participants across 7 sites.

Detailed Summary

This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedOct 8, 2020
Enrollment StartOct 27, 2020
Primary CompletionMay 28, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.7 years ago

Interventions

AD109drug

Oral administration before bed

Atomoxetinedrug

Oral administration before bed

R-oxybutynindrug

Oral administration before bed

Placebodrug

Oral administration before bed

Digit System Substitution Testother

a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.