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AD109 Dose Finding in Mild to Moderate OSA

NCT04631107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-12-22

Study results available
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Summary

This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.

Conditions

  • Obstructive Sleep Apnea

Interventions

DRUG

AD109 dose1- A

Oral administration at bedtime

DRUG

AD109 dose2- B

Oral administration at bedtime

DRUG

Placebo- C

Oral administration at bedtime

Sponsors & Collaborators

  • Apnimed

    lead INDUSTRY

Principal Investigators

  • Ron Farkas, MD · Apnimed

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-22
Primary Completion
2021-05-31
Completion
2021-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04631107 on ClinicalTrials.gov