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PF-04494700

Phase 2

Diabetic Nephropathy | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 1, 2009

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment110
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT002871836-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent AlbuminuriaPHASE2 COMPLETED 110Feb 1, 2006Aug 1, 2009Oct 1, 200919 Canada
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Study Endpoints
Primary Endpoints
Primary endpoint of efficacy will be assessed by comparing the treatment groups based on the change in urinary albumin-creatinine ratio (UACR)
from baseline to end of treatment (Month 6).
Secondary Endpoints
To evaluate treatment on estimated GFR and serum creatinine
evaluated for change from baseline to months 3 & 6
To evaluate the effects of TTP488 on other relevant biomarkers
evaluated at months 1, 3 & 6
To evaluate the safety of TTP488
Ongoing
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-04494700 (TTP488)ACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-04494700 (TTP488)DRUG60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication
PlaceboOTHERPlacebo
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Eligibility Criteria
Age Range31 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Male or female outpatients 31 years of age or older. * Females must no longer be of child-bearing potential, must have a negative serum pregnancy test, and cannot be breast-feeding. * Non-vasectomized male must be willing to abstain from sexual intercourse or willing to use a ...

Countries:Canada
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Competitive Landscape -Diabetic Nephropathy 8 trials