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MRI

Phase 1

Heart Failure, Congestive | Unknown | Cardiovascular |GSK plc|Last Updated: Jun 2, 2014

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01277679Evaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac FailurePHASE1 COMPLETED 20Jan 1, 2011Aug 1, 2011Jun 2, 20141 United Kingdom
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Study Endpoints
Primary Endpoints
Lung water distribution as measured by MRI
Visit 1 and Visit 2 will be approximately 1 week apart

MRI test

Lung water concentration as measured by MRI
Visit 1 and Visit 2 will be approximately 1 week apart

MRI test

Secondary Endpoints
Between patient variability in lung water concentration as measured by MRI at 2 independent visits
Visit 1 and Visit 2 will be approximately 1 week apart
Within patient variability in lung water concentration as measured by MRI at 2 independent visits
Visit 1 and Visit 2 will be approximately 1 week apart
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Healthy VolunteerOTHERHealthy Volunteer cohort
Heart FailureOTHERHeart Failure cohort
Interventions
NameTypeDescription
MRIPROCEDUREMRI of lungs to measure lung water content before and after passive leg raising (PLR)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Heart Failure Patients: * Established diagnosis of mild to moderate heart failure of any aetiology with symptoms defined as corresponding to the New York Heart Association (NYHA) class I, II or III * Able in the opinion of the patient and investigator to be supine for 1 hour a...

Countries:United Kingdom
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