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AZD7009, no generic name available

Phase 2

Atrial Fibrillation | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Dec 6, 2007

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00255281Efficacy and Safety of AZD7009 in the Treatment of Atrial FibrillationPHASE2 COMPLETED 160Sep 1, 2005May 1, 2006Dec 6, 200732 Denmark, Finland +6
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Study Endpoints
Primary Endpoints
The proportion of patients that have converted from AF within 90 minutes from start of infusion.
Secondary Endpoints
The time to conversion of AF from start of the infusion.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AZD7009, no generic name availableDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: * Clinical indication for cardioversion of Atrial Fibrillation. Effective oral anticoagulation according to local routines or a TEE without any finding of intracardial thrombus or signs of thrombogenecity Exclusion Criteria: * Clinically significant sinus and/or AV node dysfun...

Countries:DenmarkFinlandGermanyHungaryNetherlandsNorwayPolandSweden
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