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AVE0657

Phase 2

Sleep Apnea, Obstructive | Small molecule | Other |Sanofi|Last Updated: Jul 20, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00614250Evaluation of the Effect of AVE0657 on Obstructive Sleep ApneaPHASE2 COMPLETED 38Jan 1, 2008Jan 1, 2009Jul 20, 20093 France, Germany +1
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Study Endpoints
Primary Endpoints
Change in Apnea Hypopnea Index (AHI)
2 days
Secondary Endpoints
Safety and tolerability
5 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Level 1EXPERIMENTAL -
Dose Level 2EXPERIMENTAL -
Dose Level 3EXPERIMENTAL -
Dose Level 4EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR12 subjects: 3 subjects per dose level
Interventions
NameTypeDescription
AVE0657DRUGcapsules once a day at bedtime
placeboDRUGcapsules once a day at bedtime
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Subjects diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome based on International Classification of Sleep Disorders Exclusion Criteria: * Subjects having been treated by Continuous Positive Airway Pressure, oral appliance during 4-weeks prior to randomization * Chroni...

Countries:FranceGermanySpain
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