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GTN

Phase 1

Patients With Pace Makers But no Evidence of Ischemic Heart Disease | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 8, 2006

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00174512A Methodological Open Label Cross-Over Controlled Study To Assess The Effect Of Drugs On Ventricular Repolarization and QT Interval At Fixed Heart Rate Under Autonomic BlockadePHASE1 COMPLETED 36 — — Mar 1, 2005Jun 1, 2006Nov 8, 20066 Belgium, United Kingdom
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Study Endpoints
Primary Endpoints
QT and QTc changes at two different pacing rates in atrially paced patients
Secondary Endpoints
Change in QT and QTcF before and after Moxifloxacin with and without autonomic blockade at each pacing rate Change in QT and QTcF before and after autonomic blockade at each pacing rate
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeECT
Interventions
NameTypeDescription
GTNDRUG -
MoxifloxacinDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Patients with pace-makers but otherwise normal ventricular function Exclusion Criteria: * Nitrates, beta blockers

Countries:BelgiumUnited Kingdom
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