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AVE0657

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

AVE0657 · 1 trial · 1 indication

Phase 2 1
NCT00614250Evaluation of the Effect of AVE0657 on Obstructive Sleep ApneaSleep Apnea, Obstructive
COMPLETED38 Analytics
PHASE2COMPLETED
Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea
Sleep Apnea, ObstructiveUnlock trial analytics

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 to 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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Frequently asked questions about AVE0657

What is AVE0657 used for?

AVE0657 is an investigational small molecule being developed for the treatment of obstructive sleep apnea. It is currently in clinical development and has not been approved by regulatory authorities.

Who makes AVE0657?

AVE0657 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY.

What phase is AVE0657 in?

AVE0657 is in Phase 2 clinical development. It remains investigational and has not received regulatory approval.

What clinical trials is AVE0657 in?

AVE0657 has one completed Phase 2 clinical trial, identified as NCT00614250, which evaluated its effect on obstructive sleep apnea in 38 participants across France, Germany, and Spain.

Is AVE0657 a small molecule?

Yes, AVE0657 is a small molecule therapeutic agent. It is being studied for its potential role in treating obstructive sleep apnea.