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TAK-442

Phase 2

Venous Thromboembolism | Small molecule | Cardiovascular |Takeda Pharmaceutical Company Limited|Last Updated: Apr 13, 2016

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,045
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00641732Efficacy and Safety of TAK-442 in Subjects Undergoing Total Knee ReplacementPHASE2 COMPLETED 1,045 — — Oct 1, 2007Oct 1, 2008Apr 13, 201664 United States, Canada
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Study Endpoints
Primary Endpoints
Composite evaluation of All-Cause Mortality, Symptomatic and Asymptomatic Deep Vein Thrombosis and Symptomatic Pulmonary Embolism.
Day 10.
Incidence of Major Bleeding.
Day 10.
Secondary Endpoints
Evaluation of Major Venous Thromboembolism (composite of Symptomatic or Asymptomatic Proximal Deep Vein Thrombosis, Symptomatic Objectively Confirmed Pulmonary Embolism, and Venous Thromboembolism-Related Death).
Day 10.
Evaluation of Symptomatic Venous Thromboembolism.
Day 10.
Evaluation of Proximal Deep Vein Thrombosis.
Day 10.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
TAK-442 40 mg QDEXPERIMENTAL -
TAK-442 80 mg QDEXPERIMENTAL -
TAK-442 10 mg BIDEXPERIMENTAL -
TAK-442 20 mg BIDEXPERIMENTAL -
TAK-442 40 mg BIDEXPERIMENTAL -
TAK-442 80 mg BIDEXPERIMENTAL -
Enoxaparin 30 mg BIDACTIVE_COMPARATOR -
Interventions
NameTypeDescription
TAK-442DRUGTAK-442 40 mg, tablets, orally, once daily for up to 10 days.
EnoxaparinDRUGEnoxaparin 30 mg, syringe, subcutaneous injection, twice daily for up to 10 days.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites64

Inclusion Criteria * Scheduled to undergo elective, unilateral, primary, total knee replacement. * Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. * Scr...

Countries:United StatesCanada
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