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Stepping Up to Health

Phase 1

Type 2 Diabetes | Unknown | Cardiovascular |Johnson & Johnson|Last Updated: Jan 29, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment324
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00729040Enhancing Adherence by Building Online CommunitiesPHASE1 COMPLETED 324Jan 1, 2008Jan 1, 2009Jan 29, 2009 -
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Study Endpoints
Primary Endpoints
Total steps
last 30 days of intervention
Secondary Endpoints
dropout rate
Four months
days and hours pedometer worn
four months
login frequency
four months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORStepping Up to Health only
2EXPERIMENTALStepping up to Health PLUS online message boards to talk with other participants
Interventions
NameTypeDescription
Stepping Up to HealthBEHAVIORALInternet-mediated walking program with pedometers, goal-setting and tailored messaging
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Must have one or more of the following: Coronary artery disease (CAD); BMI 25 or higher; Type 2 diabetes * Must be sedentary, defined by less than 150 minutes of self-reported activity per week * Must be 18 or older * Must have access to a computer with an Internet connection,...

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