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KW-3902IV

Phase 2

Heart Failure, Congestive | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Jan 29, 2008

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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment82
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00159614Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal ImpairmentPHASE2 COMPLETED 30Sep 1, 2005 -Jan 29, 20086 United States
NCT00159627Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).PHASE2 COMPLETED 52Aug 1, 2004 -Jan 29, 200810 United States
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Study Endpoints
Primary Endpoints
Comparison of KW-3902IV alone or with loop diuretic on renal function.
Change in urine volume from baseline
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
KW-3902IVDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Stable congestive heart failure * Impaired renal function * Taking oral loop diuretic Exclusion Criteria: * Acutely decompensated (unstable) and end stage heart failure * Diuretics other than loop diuretics * Pregnant or nursing * Inability to follow instructions * Participa...

Countries:United States
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