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indobufen

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,372

FDA Designations

No designations recorded

Clinical trial landscape

indobufen · 1 trial · 1 indication

Phase 3 1
NCT00244426S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial FibrillationAtrial Fibrillation
COMPLETED1,372 Analytics
PHASE3COMPLETED
S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial Fibrillation
Atrial FibrillationUnlock trial analytics

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 to 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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Frequently asked questions about indobufen

What is indobufen used for?

Indobufen is an investigational small molecule being studied for the prevention of thromboembolic events in patients with nonrheumatic atrial fibrillation. It is in Phase 3 clinical development for this cardiovascular condition.

Who is developing indobufen?

Indobufen is being developed by Pfizer, Inc. (NYSE: PFE). The drug is currently in Phase 3 clinical trials for the prevention of thromboembolic events in patients with atrial fibrillation.

What phase is indobufen in?

Indobufen is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial for atrial fibrillation has been completed.

What clinical trials is indobufen in?

Indobufen was studied in a Phase 3 clinical trial with the identifier NCT00244426, titled "S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial Fibrillation." This randomized, double-blind, active-controlled trial enrolled 1,372 participants in Italy and has been completed.

Is indobufen a small molecule drug?

Yes, indobufen is a small molecule drug. It is being investigated for use in atrial fibrillation, a cardiovascular condition, and is currently in Phase 3 clinical development.