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LY517717

Phase 2

Total Knee Replacement | Small molecule | Other |Eli Lilly and Company|Last Updated: Mar 31, 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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment511
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00074828New Oral Anticoagulant Therapy for the Prevention of Blood Clots Following Hip or Knee Replacement SurgeryPHASE2 COMPLETED 511 — — Dec 1, 2003May 1, 2005Mar 31, 20088 Australia, Austria +6
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Study Endpoints
Primary Endpoints
Efficacy of LY517717 to enoxaparin in the prevention of VTEs measured by the proportion of patients with VTE event (DVT and/or PE) as confirmed by bilateral venography or on clinical assessment
end of study drug administration
Secondary Endpoints
Safety and tolerability, major and minor bleeding, death due to VTE, effect on QTc duration, AEs and SAEs, hepatobiliary and other safety lab parameters
baseline, daily during therapy, at follow up visit
Pharmacokinetics and pharmacodynamics
predose, daily during therapy
Compare the effect of LY517717 versus enoxaparin measured by DVT, Proximal DVT, Distal DVT and PE
end of study drug administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BACTIVE_COMPARATOR -
Interventions
NameTypeDescription
LY517717DRUG -
enoxaparinDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Are scheduled for total knee or hip replacement surgery (only one side, first time joint replacement) * Are at least 18 years of age and no more than 75 years of age. * Have a body weight more than 50 kg and less than 120 kg. * Sign an approved Eli Lilly and Company informed c...

Countries:AustraliaAustriaBelgiumCzechiaGermanyHungaryItalyPoland
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