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Lapaquistat and fenofibrate

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment213

FDA Designations

No designations recorded

Clinical trial landscape

Lapaquistat and fenofibrate · 1 trial · 1 indication

Phase 2 1
NCT00813527Effect of Lapaquistat Acetate Combined With Fenofibrate on Blood Cholesterol LevelsHyperlipidemias
COMPLETED213 Analytics
PHASE2COMPLETED
Effect of Lapaquistat Acetate Combined With Fenofibrate on Blood Cholesterol Levels
Hyperlipidemias
NCT00813527213
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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 to 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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Frequently asked questions about Lapaquistat and fenofibrate

What is Lapaquistat used for?

Lapaquistat is an investigational small molecule being developed for Type 2 Diabetes, Dyslipidemia, Hypercholesterolemia, and Hyperlipidemias. It is in Phase 3 clinical development for these cardiovascular conditions. The drug is not approved and remains under investigation.

Who makes Lapaquistat?

Lapaquistat is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is an investigational small molecule in Phase 3 clinical development for cardiovascular indications including dyslipidemia and hypercholesterolemia.

What phase is Lapaquistat in?

Lapaquistat is in Phase 3 clinical development. It is an investigational drug and has not been approved. Seven clinical trials have been completed, with no active trials currently ongoing. The trials enrolled a total of 4,649 participants.

What clinical trials is Lapaquistat in?

Lapaquistat has completed seven clinical trials, including NCT00143663, NCT00256178, NCT00487994, and NCT00864643. These Phase 3 and Phase 2 trials studied the drug's effects on cholesterol levels in patients with dyslipidemia and hypercholesterolemia, both alone and with statins like simvastatin and atorvastatin.

Is Lapaquistat the same as Lapaquistat Acetate?

Lapaquistat is the same as Lapaquistat Acetate. Clinical trials refer to the drug as Lapaquistat Acetate, which is the active pharmaceutical ingredient being studied in patients with dyslipidemia and hypercholesterolemia.