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AD113 for Obstructive Sleep Apnea

Phase 2
Waitlist Available
Research Sponsored by Apnimed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days of treatment per crossover arm
Awards & highlights

Study Summary

This trial compares atomoxetine with AD113 to see if it's more effective in treating patients with moderate to severe OSA and controlled hypertension.

Eligible Conditions
  • Obstructive Sleep Apnea
  • High Blood Pressure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days of treatment per crossover arm
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days of treatment per crossover arm for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve)
Secondary outcome measures
Change in Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)

Trial Design

2Treatment groups
Experimental Treatment
Group I: AtomoxetineExperimental Treatment1 Intervention
Two oral capsules administered before bed
Group II: AD113Experimental Treatment1 Intervention
Two oral capsules administered before bed
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AD113
2021
Completed Phase 2
~30
Atomoxetine
2010
Completed Phase 4
~431790

Find a Location

Who is running the clinical trial?

ApnimedLead Sponsor
13 Previous Clinical Trials
2,014 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has research involving the drug AD113 been conducted before?

"Currently, 12 research initiatives are in progress that focus on AD113 with 2 of them having reached Phase 3. Most experiments involving this drug are located in Lisboa and California; nevertheless, 86 other medical sites have initiated their own trials for the same compound."

Answered by AI

Are there vacancies available in this clinical trial?

"The trial is not currently accepting participants. It was first uploaded to the website on July 31st 2021, and its most recent update occured November 14th 2022. If you are in search of other studies, there are 979 related trials for hypertension enrolling patients at this time, along with 12 clinical investigations pertaining to AD113 that remain open for applicants."

Answered by AI

What is the eligibility criteria for this experiment?

"The admission criteria for this study is hypertension and an age range between 25 to 65 years old. 21 participants are being accepted into the trial overall."

Answered by AI

Could individuals below the age of 40 be allocated to this scientific experiment?

"The age requirements for inclusion in this trial dictate that participants must be over 25 but not older than 65."

Answered by AI

Has the AD113 drug been accepted by the US Food and Drug Administration?

"Due to the lack of efficacy data, AD113's safety rating is assessed as 2. This Phase 2 trial does have evidence supporting its security profile."

Answered by AI

What is the maximum number of participants for this clinical experiment?

"At this time, recruitment for the trial has ended, as it was last amended on November 14th 2022. Nonetheless, if you are looking to participate in similar studies there are currently 979 trials recruiting hypertension patients and 12 more studies admitting participants with AD113."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
PCCAB
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Trying to find something better then machine and Ethos.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long is each visit?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Trial of AD113 and Atomoxetine in OSA Patients With Hypertension
2021. "Trial of AD113 and Atomoxetine in OSA Patients With Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04905979.
~6 spots leftby May 2025
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