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Rivastigmine prevention of delirium

Phase 3

Delirium | Small molecule | Psychiatry |Novartis AG|Last Updated: Jul 31, 2007

Development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Nov 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Rivastigmine prevention of delirium · 1 trial · 1 indication

Phase 3 1
NCT00257868Rivastigmine for the Prevention of Postoperative Delirium in Patients Undergoing Cardiac SurgeryDelirium
COMPLETED120 Analytics
PHASE3COMPLETED
Rivastigmine for the Prevention of Postoperative Delirium in Patients Undergoing Cardiac Surgery
Delirium
NCT00257868120
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Study Endpoints

Primary Endpoints

Development of postoperative delirium within 7 days after cardiac surgery

Secondary Endpoints

Severity of delirium occurring within 7 days after cardiac surgery
Length of stay (intensive care and hospital)
Amount of drugs used for rescue therapy of delirium
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Rivastigmine prevention of deliriumDRUG -
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients undergoing cardiac surgery with use of extracorporeal circulation * Aged 65 or more Exclusion Criteria: * "redo" procedures * anticipated use of succinylcholine during operation * contraindications to rivastigmine * preoperative mini mental score \< 15

Countries:Switzerland
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