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SAS0421a

Phase 1/2

Sleep Apnea | Small molecule | Other |Apnimed, Inc.|Trials Updated: Mar 2, 2022

SAS0421a development status

Highest phase Phase 1/2 (NCT03892772)
Phase scored for APMDPhase 1
Registered trials 1 across 1 sponsor since Mar 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

SAS0421a clinical trials

SAS0421a · 1 trial · 1 indication

Phase 1/2 1
NCT03892772Combination Pharmacological Interventions for Multiple Mechanisms of Obstructive Sleep ApneaSleep Apnea
COMPLETED23 Analytics
PHASE1/PHASE2COMPLETED
Combination Pharmacological Interventions for Multiple Mechanisms of Obstructive Sleep Apnea
Sleep ApneaUnlock trial analytics

Study Endpoints

Primary Endpoints

Apnea-hypopnea index [AHI]
3 days

Apneas and hypopneas per hour (3% desat and/or arousal), % change from baseline

Secondary Endpoints

Hypoxic Burden
3 days
Arousal Index
3 days
Visual Analog Scale for Sleep Quality
3 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAS0421a, SAS0421b and SAS0421cEXPERIMENTALParticipants will take SAS0421a, SAS0421b and SAS0421c for 3 days. Half doses will be given on the first night.
SAS0421a and SAS0421bACTIVE_COMPARATORParticipants will take SAS0421a and SAS0421b for 3 days. Half doses will be given on the first night.
SAS0421cACTIVE_COMPARATORParticipants will take SAS0421c for 3 days. Half doses will be given on the first night.
PlaceboPLACEBO_COMPARATORParticipants will take placebos for 3 days.

Interventions

NameTypeDescription
SAS0421aDRUGtreatment will be given for 3 days
SAS0421bDRUGtreatment will be given for 3 days
SAS0421cDRUGtreatment will be given for 3 days
placeboDRUGplacebo will be given for 3 days
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Eligibility Criteria

Age Range18 Years to 79 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria: * Ages 18 - 79 years * Suspected or diagnosed OSA Exclusion criteria: * Any uncontrolled medical condition * Current use of the medications under investigation * Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, doxapram, almitri...

Countries:United StatesAustralia
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