Recent Updates
Recently added Catalysts

Lapaquistat and lipid-lowering therapy

Phase 3

Type 2 Diabetes | 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
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00251680Efficacy of Lapaquistat Acetate in Subjects Currently Treated With Lipid-Lowering Therapy.PHASE3 COMPLETED 400Oct 1, 2005May 1, 2007May 24, 201277 United States, Czechia +7
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol
Week 24 or Final Visit
Secondary Endpoints
Change from Baseline in Triglycerides
Week 24 or Final Visit
Change from Baseline in Total Cholesterol
Week 24 or Final Visit
Change from Baseline in High Density Lipoprotein cholesterol
Week 24 or Final Visit
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Lapaquistat Acetate 50 mg QDEXPERIMENTAL(and stable lipid-lowering therapy)
Stable Lipid-lowering therapyACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Lapaquistat acetate and lipid-lowering therapyDRUGLapaquistat acetate 50 mg, tablets, orally, once daily and stable lipid-lowering therapy for up to 24 weeks.
Lipid-lowering therapyDRUGLapaquistat acetate placebo-matching tablets, tablets, orally, once daily and stable lipid-lowering therapy for up to 24 weeks.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites77

Inclusion Criteria: * Females of childbearing potential who are sexually active must agree to use adequate contraception from screening throughout the duration of the study and for 30 days following the last dose. * Has a documented history of dyslipidemia with or without cardiovascular risk factor...

Countries:United StatesCzechiaEstoniaFinlandGermanyPolandSlovakiaSouth AfricaUnited Kingdom
Unlock Eligibility Criteria