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TAK-442

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment2,753

FDA Designations

No designations recorded

Clinical trial landscape

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 treatment of Acute Coronary Syndrome and Venous Thromboembolism. It is in Phase 2 clinical development and is not approved by the FDA. TAK-442 is being developed by Takeda Pharmaceutical Company Limited.

What does TAK-442 target?

TAK-442 is a small molecule that targets factor Xa, a key enzyme in the coagulation cascade. By inhibiting factor Xa, TAK-442 is designed to reduce blood clot formation, which is relevant to its potential use in Acute Coronary Syndrome and Venous Thromboembolism.

Who makes TAK-442?

TAK-442 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is conducting clinical trials to evaluate the safety and efficacy of TAK-442 in patients with cardiovascular conditions.

What phase is TAK-442 in?

TAK-442 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 2 trials have been completed, one in Venous Thromboembolism and one in Acute Coronary Syndrome.

What clinical trials is TAK-442 in?

TAK-442 has been studied in two completed Phase 2 trials. NCT00641732 evaluated TAK-442 in patients undergoing total knee replacement for Venous Thromboembolism, enrolling 1,045 participants. NCT00677053 evaluated TAK-442 in patients with Acute Coronary Syndromes, enrolling 2,753 participants.

Is TAK-442 the same as any other drug?

TAK-442 is also known by its chemical name, and it is a direct factor Xa inhibitor. It is not the same as other marketed anticoagulants, as it is a distinct investigational compound developed by Takeda. No alternative brand names have been established.