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medical food with AN777, nutritional formula

Phase 3

Malnutrition | Unknown | Other |Abbott Laboratories|Last Updated: Mar 7, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment331
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01191125Evaluation of an Oral Nutritional Supplement Containing AN777PHASE3 COMPLETED 331Feb 1, 2011Sep 1, 2012Mar 7, 201323 United States, Belgium +6
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Study Endpoints
Primary Endpoints
Knee extensor strength
Six months
Secondary Endpoints
Leg muscle mass
Six months
Body Weight
Six months
Functional measures
Six months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
medical food with AN777EXPERIMENTAL -
oral nutritional formulaACTIVE_COMPARATOR -
Interventions
NameTypeDescription
medical food with AN777OTHERTwo(220 mL)servings every day for six months
oral nutritional formulaOTHERTwo (220 mL) servings daily for six months
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Eligibility Criteria
Age Range65 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: Subject (male or female) is \> or equal to 65 and \< or equal to 90 years of age Subject is ambulatory Subject has a Subjective Global Assessment of B or C Subject has gait speed \<0.8 m/s AND/OR low hand-grip strength Subject has Class 1 or Class 2 sarcopenia Subject agree...

Countries:United StatesBelgiumItalyMexicoPolandSpainSwitzerlandUnited Kingdom
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