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AD113

Phase 2

Obstructive Sleep Apnea | Small molecule | Cardiovascular |Apnimed, Inc.|Trials Updated: Aug 21, 2023

AD113 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since May 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

AD113 clinical trials

AD113 · 1 trial · 2 indications

Phase 2 1
NCT04905979Trial of AD113 and Atomoxetine in OSA Patients With HypertensionObstructive Sleep Apnea
COMPLETED21 Analytics
PHASE2COMPLETED
Trial of AD113 and Atomoxetine in OSA Patients With Hypertension
Obstructive Sleep Apnea
NCT0490597921
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Study Endpoints

Primary Endpoints

Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve)
10 days of treatment per crossover arm

Change in HB for AD113 vs. atomoxetine measured by polysomnography atomoxetine

Secondary Endpoints

Change in Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
10 days of treatment per crossover arm
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AD113EXPERIMENTALTwo oral capsules administered before bed
AtomoxetineEXPERIMENTALTwo oral capsules administered before bed

Interventions

NameTypeDescription
AD113DRUGTwo oral capsules administered before bed
AtomoxetineDRUGTwo oral capsules administered before bed
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Eligibility Criteria

Age Range25 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Between 25 to 65 years of age, inclusive, at the Screening Visit. * AHI 10 to 50 (hypopneas defined by 4% oxygen desaturation) * History of hypertension or blood pressure at Visit 1 ≥130/80 mmHg Exclusion Criteria: * History of narcolepsy. * Clinically significant craniofaci...

Countries:United States
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