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TAK-442

Phase 2

Acute Coronary Syndrome | Small molecule | Cardiovascular |Takeda Pharmaceutical Company Limited|Trials Updated: Apr 13, 2016

TAK-442 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Mar 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment3,798

FDA Designations

No designations recorded

TAK-442 clinical trials

TAK-442 · 2 trials · 2 indications

Phase 2 2
NCT00677053Safety and Efficacy of TAK-442 in Subjects With Acute Coronary SyndromesAcute Coronary Syndrome
COMPLETED2,753 Analytics
NCT00641732Efficacy and Safety of TAK-442 in Subjects Undergoing Total Knee ReplacementVenous Thromboembolism
COMPLETED1,045 Analytics
PHASE2COMPLETED
Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes
Acute Coronary SyndromeUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of TAK-442 in Subjects Undergoing Total Knee Replacement
Venous ThromboembolismUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Major Bleeding Events defined by the Thrombolysis in Myocardial Infarction Scale.
On Occurrence (Up to 24 weeks)
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

Composite of Cardiovascular Mortality, non-fatal Myocardial Infarction, non-fatal Stroke, or Myocardial Ischemia requiring hospitalization.
Week 24
Cardiovascular Mortality.
Week 24.
Non-fatal Myocardial Infarction.
Week 24.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TAK-442 10 mg BIDEXPERIMENTALAdded with standard care for recurrent ischemic events.
TAK-442 20 mg BIDEXPERIMENTALAdded with standard care for recurrent ischemic events
TAK-442 40 mg QDEXPERIMENTALAdded with standard care for recurrent ischemic events
TAK-442 40 mg BIDEXPERIMENTALAdded with standard care for recurrent ischemic events
TAK-442 80 mg QDEXPERIMENTALAdded with standard care for recurrent ischemic events
TAK-442 80 mg BIDEXPERIMENTALAdded with standard care for recurrent ischemic events
TAK-442 160 mg QDEXPERIMENTALAdded with standard care for recurrent ischemic events
TAK-442 120 mg BIDEXPERIMENTALAdded with standard care for recurrent ischemic events
PlaceboPLACEBO_COMPARATORAdded with standard care for recurrent ischemic events
Enoxaparin 30 mg BIDACTIVE_COMPARATOR -

Interventions

NameTypeDescription
TAK-442DRUGStage I: TAK-442 10 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
PlaceboDRUGStages I, II \& III: TAK-442 placebo-matching capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
EnoxaparinDRUGEnoxaparin 30 mg, syringe, subcutaneous injection, twice daily for up to 10 days.
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Eligibility Criteria

Age Range30 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites103

Inclusion Criteria: * Has been hospitalized for acute coronary syndrome * Is able to initiate study drug if: * The index event occurred within the past 7 days (the date of initial hospitalization will be utilized for the date on which the index event occurred), and * The final acute medical or...

Countries:United StatesArgentinaBelgiumBrazilBulgariaCanadaChileEstoniaGermanyHungaryIndiaNetherlandsPeruRomaniaRussiaSerbiaSouth AfricaSouth KoreaUnited Kingdom
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Frequently asked questions about TAK-442

What is TAK-442 used for?

TAK-442 is an investigational small molecule being studied for the prevention and treatment of venous thromboembolism and for use in patients with acute coronary syndrome. It was evaluated in Phase 2 clinical trials for these cardiovascular conditions, though it is not approved and remains in clinical development.

Who makes TAK-442?

TAK-442 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company sponsored the Phase 2 clinical trials for this investigational cardiovascular drug.

What phase is TAK-442 in?

TAK-442 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in venous thromboembolism and one in acute coronary syndrome. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is TAK-442 in?

TAK-442 has completed two Phase 2 trials. NCT00641732 evaluated its efficacy and safety in 1,045 subjects undergoing total knee replacement for venous thromboembolism. NCT00677053 assessed its safety and efficacy in 2,753 subjects with acute coronary syndromes across multiple countries.

Is TAK-442 the same as any other drug?

TAK-442 is the sole name provided for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information.