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auto-titrating continuous positive airway pressure

Phase 2

Transient Ischemic Attack | Unknown | Other |Johnson & Johnson|Last Updated: Mar 3, 2009

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment62
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00251290Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic AttackPHASE2 COMPLETED 62 — — Nov 1, 2004Sep 1, 2007Mar 3, 20093 United States
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Study Endpoints
Primary Endpoints
prevalence of sleep-disordered breathing in patients with TIA, proportion of patients who use auto-CPAP >4 hours per night, and change in systolic blood pressure
90 days
Secondary Endpoints
Recurrent vascular events (transient ischemic attack, stroke, myocardial infarction, congestive heart failure requiring hospitalization, and death), sleepiness, cognition, depression, functional status, and quality of life.
90 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
auto-titrating continuous positive airway pressurePROCEDUREContinuous positive Airway pressure (CPAP) use for 90 days post TIA
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Eligibility Criteria
Age Range45 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: transient ischemic attack - Exclusion Criteria:age \<45 years; respiratory distress or known sleep-disordered breathing; chronic obstructive pulmonary disease (COPD) requiring oxygen; pregnancy; time from symptom onset to beginning of study intervention 72 hours; life expectancy ...

Countries:United States
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