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Parallel Arm Trial of AD109 and AD504 In Patients With OSA

NCT05071612 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2022-12-12

No results posted yet for this study

Summary

This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.

Conditions

  • OSA - Obstructive Sleep Apnea

Interventions

DRUG

AD109

Oral administration at bedtime

DRUG

AD504

Oral administration at bedtime

DRUG

Atomoxetine Hydrochloride

Oral administration at bedtime

DRUG

Placebo

Oral administration at bedtime

Sponsors & Collaborators

  • Apnimed

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2022-07-20
Completion
2022-08-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05071612 on ClinicalTrials.gov