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Renal Artery Stent with Protective Device/Drug

Phase 2

Renal Artery Stenosis | Unknown | Nephrology |Johnson & Johnson|Last Updated: Dec 10, 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00234585Prospective Randomized Study Comparing Renal Artery Stenting (RESIST)With/Without Distal ProtectionPHASE2 COMPLETED 100Aug 1, 2002Jun 1, 2007Dec 10, 20141 United States
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Study Endpoints
Primary Endpoints
Glomerular Filtration Rate
Adverse Events
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Renal Artery Stent with Protective Device/DrugDEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Any one or more of the following: Meet Angiographic criteria plus * Systemic hypertension at baseline, or a history of hypertension * Congestive heart failure at baseline, or a history of CHF * Renal insufficiency at baseline, or a history of renal insufficiency * Angina, or a...

Countries:United States
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