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MRI scan

Phase 1

Atrophy, Muscular | Unknown | Other |GSK plc|Last Updated: Jul 1, 2013

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
NO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment75
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT0147607231P MRS Ischaemic Exercise Optimisation and COPDPHASE1 COMPLETED 75Apr 1, 2010Aug 1, 2011Jul 1, 20131 United Kingdom
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Study Endpoints
Primary Endpoints
level of skeletal muscle metabolism
1 year

ADP, ATP, PCr, Pi, and pH will be measured during rest, anaerobic exercise and recovery to determine muscle metabolism.

Secondary Endpoints
determine Markers of disease in patients with COPD-related myopathy
1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
no treatmentNO_INTERVENTIONMRI scans only
Interventions
NameTypeDescription
MRI scanOTHERMRI scan only, methodology study with no other intervention
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Fit to safely tolerate procedures 2. Male or female between 18 and 80 years of age 3. If pre-menopausal female, non-pregnant on dipstick urinalysis 4. Subject and responsible physician agree that the subject will be able to comfortably lie in scanning position in the scanner ...

Countries:United Kingdom
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