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BMS-914392

Phase 2

Atrial Fibrillation | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Oct 12, 2015

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-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01356914Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation BurdenPHASE2 COMPLETED 20May 1, 2011Jun 1, 2012Oct 12, 20151 United Kingdom
NCT01211821Effect of BMS-914392 on Pharmacokinetics of MetoprololPHASE1 COMPLETED 18Sep 1, 2010Nov 1, 2010Feb 2, 20111 United States
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Study Endpoints
Primary Endpoints
Atrial Fibrillation Burden
At screening (baseline)
Pharmacokinetics of single dose of metoprolol derived from serial measurements of metoprolol plasma concentrations
Pre-dose and 0.5 Hr, 1 Hr, 1.5 Hr, 2 Hr, 3 Hr, 4 Hr, 6 Hr, 8 Hr, 12 Hr, 24 Hr, and 36 Hr after dosing of metoprolol alone or in combination with BMS-914392
Secondary Endpoints
Number of participants with adverse events and type of adverse events
At Day 1 of each cross-over period
Number of Atrial fibrillation (AF) episodes
At Day 1 of each cross-over period
Number of AF episodes
At Day 8 of each cross-over period
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment A: BMS-914392EXPERIMENTAL -
Treatment B: BMS-914392EXPERIMENTAL -
Treatment C: BMS-914392EXPERIMENTAL -
Treatment D: PlaceboPLACEBO_COMPARATOR -
metoprololOTHERTreatment A
BMS-914392 + metoprololEXPERIMENTALTreatment B
Interventions
NameTypeDescription
BMS-914392DRUGTablets, Oral, 10 mg, Every Day (QD), 20 days
PlaceboDRUGTablets, Oral, 0 mg, Three Times Daily (TID), 20 days
metoprololDRUGTablets, Oral, 200 mg, once, 1 day
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Paroxysmal atrial fibrillation (AF) * Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics. * 1-50% AF burden on pacemaker interrogation at screening. * Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception t...

Countries:United KingdomUnited States
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