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AVE7688

Phase 2

Hypertension | Small molecule | Cardiovascular |Sanofi|Last Updated: May 18, 2016

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment1,940
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00284128AVE7688 in Patients With Mild to Moderate Blood PressurePHASE2 COMPLETED 1,940Dec 1, 2005Mar 1, 2008May 18, 201621 United States, Argentina +19
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Study Endpoints
Primary Endpoints
Change from baseline in trough diastolic blood pressure at the end of week 12.
12 weeks
Secondary Endpoints
Change from baseline in trough systolic blood pressure at the end of week 12, percentages of responders after 12 week of treatment.
12 weeks
Evaluation of long term safety and tolerability of AVE7688 with particular attention to angioedema.
12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ilepatril (2.5 mg ) once dailyEXPERIMENTALAVE7688 oral administration
ilepatril (10 mg) once dailyEXPERIMENTALAVE7688 oral administration
ilepatril (35 mg) once dailyEXPERIMENTALAVE7688 oral administration
ilepatril (50 mg) once dailyEXPERIMENTALAVE7688 oral administration
Losartan-potassium (100 mg) once dailyOTHERoral administration
Interventions
NameTypeDescription
AVE7688DRUGoral administration (capsules)
Losartan-potassiumDRUGoral administration (capsules)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Patients with mild-to-moderate, treated or untreated, essential hypertension, as defined by the JNC VII (Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, Seventh report ) guidelines who meet the following BP eligibility ...

Countries:United StatesArgentinaBrazilCanadaChileGermanyGreeceHong KongItalyMalaysiaMexicoNetherlandsPolandPortugalRussiaSingaporeSouth AfricaSouth KoreaSpainTaiwanTurkey (Türkiye)
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