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AD182

Phase 2

Obstructive Sleep Apnea | Small molecule | Respiratory |Apnimed, Inc.|Trials Updated: Sep 2, 2022

AD182 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Nov 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

AD182 clinical trials

AD182 · 1 trial · 1 indication

Phase 2 1
NCT04645524Crossover Trial of AD182 and AD504 in Obstructive Sleep ApneaObstructive Sleep Apnea
COMPLETED15 Analytics
PHASE2COMPLETED
Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea
Obstructive Sleep Apnea
NCT0464552415
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Study Endpoints

Primary Endpoints

Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
1 night (treatment duration)

Apnea-Hypopnea Index, AD182 and AD504 vs placebo

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AD182EXPERIMENTALOral capsule administered before bed
AD504EXPERIMENTALOral capsule administered before bed
PlaceboPLACEBO_COMPARATOROral capsule administered before bed

Interventions

NameTypeDescription
AD182DRUGOral capsule administered before bed
AD504DRUGOral capsule administered before bed
PlaceboDRUGOral capsule administered before bed
PolysomnographyDIAGNOSTIC_TESTfor all arms
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Eligibility Criteria

Age Range25 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female between 25 and 65 years of age, inclusive, at the time of the screening visit * AHI 10 to 55 events/h if meets other PSG criteria Exclusion Criteria: * History of narcolepsy. * Clinically significant craniofacial malformation. * Clinically significant cardiac ...

Countries:United States
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