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Trial of AD036 in Obstructive Sleep Apnea

NCT03845023 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-01-17

Study results available
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Summary

This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus placebo in patients with obstructive sleep apnea.

Conditions

  • Obstructive Sleep Apnea

Interventions

DRUG

AD036 Dose 1

AD036 Dose 1 oral capsule administered before sleep

DRUG

AD036 Dose 2

AD036 Dose 2 oral capsule administered before sleep

DRUG

AD036 Dose 3

AD036 Dose 3 oral capsule administered before sleep

DRUG

Placebo

Placebo oral capsule administered before sleep

Sponsors & Collaborators

  • Apnimed

    lead INDUSTRY

Principal Investigators

  • Ron Farkas, MD · Apnimed

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-07
Primary Completion
2019-10-23
Completion
2019-10-23
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 NCT03845023 on ClinicalTrials.gov