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Eprosartan

Phase 3

Essential Hypertension | Small molecule | Cardiovascular |Abbott Laboratories|Last Updated: Jul 25, 2014

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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment665
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01631227Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential HypertensionPHASE3 COMPLETED 665Jun 1, 2012Apr 1, 2013Jul 25, 201438 Germany, Russia +1
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Study Endpoints
Primary Endpoints
Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline
8 weeks

Change from baseline of diastolic blood pressure (DBP), sitting

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EprosartanEXPERIMENTALEprosartan + Placebo Eprosartan Mesylate
Eprosartan MesylateACTIVE_COMPARATOREprosartan Mesylate + Placebo Eprosartan
Interventions
NameTypeDescription
EprosartanDRUGEprosartan 450 mg
Eprosartan MesylateDRUGEprosartan mesylate 600 mg
Placebo Eprosartan mesylateDRUGPlacebo Eprosartan mesylate
Placebo EprosartanDRUGPlacebo Eprosartan
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria * Males or females with essential hypertension, blood pressure values between 140 mmHg and 179 mmHg systolic and between 90 mmHg and 109 mmHg diastolic * Given written informed consent prior to starting the study Exclusion Criteria * Women with childbearing potential, breast fe...

Countries:GermanyRussiaUnited Kingdom
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