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INR self-testing program

Phase 3

Mechanical Aortic and/or Mitral Valve Replacement Operation | Unknown | Cardiovascular |Abbott Laboratories|Last Updated: Jun 22, 2009

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment206
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00925197Patient International Normalised Ratio (INR) Self-Testing ProgramPHASE3 COMPLETED 206May 1, 2004Jan 1, 2009Jun 22, 2009 -
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Study Endpoints
Primary Endpoints
Hemorrhagic events and thromboembolic events
after mechanical heart valve replacement
Secondary Endpoints
Correlation of laboratory INR and device INR control
after mechanical heart valve replacement
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
Interventions
NameTypeDescription
INR self-testing programOTHER -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * adults * patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization * oral anticoagulant treatment * patients with social security cover * written informed consent signed by both patient and investigator * able to ...

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