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Lapaquistat and fenofibrate

Phase 2

Hyperlipidemias | Small molecule | Metabolic |Takeda Pharmaceutical Company Limited|Last Updated: May 24, 2012

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment213
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00813527Effect of Lapaquistat Acetate Combined With Fenofibrate on Blood Cholesterol LevelsPHASE2 COMPLETED 213Feb 1, 2006Jan 1, 2007May 24, 201236 United States, Canada
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Study Endpoints
Primary Endpoints
Percent change from Baseline in direct fasting plasma low-density lipoprotein cholesterol.
Week 12 or Final Visit.
Secondary Endpoints
Change from baseline in calculated low-density lipoprotein cholesterol.
Week 12 or Final Visit.
Change from baseline in non- high-density lipoprotein cholesterol.
Week 12 or Final Visit.
Change from baseline in total cholesterol.
Week 12 or Final Visit.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Lapaquistat Acetate 100 mg QD + Fenofibrate 145 mg QDEXPERIMENTAL -
Fenofibrate 145 mg QDACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Lapaquistat acetate and fenofibrateDRUGLapaquistat acetate 100 mg, tablets, orally, once daily and fenofibrate 145 mg, tablets, orally, once daily for up to 12 weeks.
FenofibrateDRUGLapaquistat acetate placebo-matching tablets, orally, once daily and fenofibrate 145 mg, tablets, orally, once daily for up to 12 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: * Women of childbearing potential must not be pregnant as determined by a negative serum human chorionic gonadotropin, not lactating, not planning on becoming pregnant between Screening and 30 days following the last dose of study medication, and agreed to use acceptable forms o...

Countries:United StatesCanada
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