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ECMPS-IEM

Phase 2

Detection Accuracy | Small molecule | Other |Novartis AG|Last Updated: Feb 23, 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
UNCONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01320358Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant PatientsPHASE2 COMPLETED 30 — — May 10, 2011Nov 18, 2011Feb 23, 20175 Switzerland
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Study Endpoints
Primary Endpoints
To assess the reliability of the Raisin technology defined as accuracy and precision in detecting directly observed ingestion of ECMPS-IEM and Placebo-IEM.
12 weeks
Secondary Endpoints
the adherence (taking and scheduling) to prescribed ECMPS-IEM schedule with and without active feedback for two consecutive periods of 8 and 4 weeks each.
12 weeks
the incidence and severity of adverse events observed during the utilization of the ECMPS-IEM and Proteus Personal Monitor (patch).
12 weeks
the satisfaction and usability of the TSS by patients
12 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
ECMPS-IEMEXPERIMENTAL -
Interventions
NameTypeDescription
ECMPS-IEMDRUGECMPS-IEM
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patients at least 6 months post-transplantation and in stable clinical condition * Treatment with ECMPS doses between 720 mg/day and 1440 mg/day or MMF doses between1000 mg/day and 2000 mg/day, divided in two equal doses 12 hours apart and with no dose titrations planned for t...

Countries:Switzerland
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