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Fluvastatin

Phase 3

Mixed Dyslipidemia | Small molecule | Metabolic |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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment325
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00136799Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary HypercholesterolemiaPHASE3 COMPLETED 325 — — Jun 1, 2005Apr 1, 2006Feb 23, 20171 China
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Study Endpoints
Primary Endpoints
Percent change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary Endpoints
Percent change from baseline in total cholesterol after 12 weeks
Percent change from baseline in high density lipoprotein cholesterol after 12 weeks
Percent change from baseline in total triglycerides after 12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
FluvastatinDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Mixed dyslipidemia * Primary hypercholesterolemia Exclusion Criteria: * Pregnant or lactating women * Age \> 18 years Other protocol-defined inclusion and exclusion criteria may apply.

Countries:China
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