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PAL-40 Active

Phase 3

End Stage Renal Disease | Small molecule | Nephrology |Abbott Laboratories|Last Updated: Oct 15, 2010

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
Double-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment2,003
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00032435Homocysteine Study (HOST)PHASE3 COMPLETED 2,003May 1, 2001Sep 1, 2006Oct 15, 201037 United States, Puerto Rico
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Study Design & Arms
MaskingDOUBLE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALPAL-40 Active
2PLACEBO_COMPARATORPAL-40 Placebo
Interventions
NameTypeDescription
PAL-40 ActiveDRUG -
PAL-40 PlaceboDRUG -
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: Patients will be screened by their plasma homocysteine concentration. They must have a level of at least 15 mM/L to be enrolled in the study. Patients will be excluded by any of the following criteria: age less than 21 years, expected life span less than 6 months, pregnancy, me...

Countries:United StatesPuerto Rico
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