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EC-MPS

Phase 3

Patients Successfully Completing the 12-month Treatment Period of the Core Study (de Novo Heart Recipients) Who Were Interested of Being Treated With EC-MPS | Small molecule | Other |Novartis AG|Last Updated: Feb 24, 2017

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 Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00238446Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Heart Transplant RecipientsPHASE3 COMPLETED -Apr 1, 2003 -Feb 24, 2017 -
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Interventions
NameTypeDescription
EC-MPSDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: Patients who were participating in the core study CERL080A2401 and have successfully completed the first 12 months of the core study Exclusion Criteria: Patients who did not complete the 12-month core study CERL080A2401 Other protocol-defined inclusion/exclusion criteria may ...

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