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fluvastatin, ezetimibe

Phase 3

Dyslipidemia | Small molecule | Metabolic |Novartis AG|Last Updated: Nov 8, 2011

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment83
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00171288Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin AlonePHASE3 COMPLETED 83Aug 1, 2003Aug 1, 2005Nov 8, 20111 Spain
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Study Endpoints
Primary Endpoints
Change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary Endpoints
Change from baseline in total triglyceride, high density lipoprotein cholesterol, and composition of low density lipoprotein cholesterol after 12 weeks
Change from baseline in circulating marker of inflammation after 12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
fluvastatin, ezetimibeDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients aged 18-75 Primary hypercholesterolemia Signed informed consent Exclusion Criteria: * Patients involved in clinical trials 3 months prior to inclusion Patients treated with drugs specified in protocol Fertile women not using contraceptive methods Other protocol def...

Countries:Spain
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