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indobufen

Phase 3

Atrial Fibrillation | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: Dec 19, 2018

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 Enrollment1,372
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00244426S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial FibrillationPHASE3 COMPLETED 1,372Dec 1, 2000Apr 1, 2008Dec 19, 2018132 Italy
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Study Endpoints
Primary Endpoints
combined endpoints: cerebral ictus (ischemic or haemorragic), cardiovascular death, nonfatal acute myocardial infarction (AMI) or peripheral embolism. The first event occurring during the study will be considered.
3.5 years
Secondary Endpoints
Global mortality, ischemic ictus, disabling ictus, TIA, nonfatal acute myocardial infarction, fatal and nonfatal hemorrhagic events, fatal and nonfatal embolisms.
3.5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
indobufenDRUGIndobufen capsules 100 and 200mg
aspirinDRUGAcetylsalicylic acid capsules 300mg
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites132

Inclusion Criteria: * Chronic or paroxysmal non rheumatic atrial fibrillation with cardioembolic risk factors: hypertension, ischemic cardiopathy, Congestive Heart Failure, diabetes mellitus Exclusion Criteria: * Clinically relevant organ disease * creatinine clearance \< 30 ml/min * gastric or d...

Countries:Italy
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