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Lapaquistat and lipid-lowering therapy

Phase 3

Type 2 Diabetes | 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 Enrollment400

FDA Designations

No designations recorded

Clinical trial landscape

Lapaquistat and lipid-lowering therapy · 1 trial · 1 indication

Phase 3 1
NCT00251680Efficacy of Lapaquistat Acetate in Subjects Currently Treated With Lipid-Lowering Therapy.Type 2 Diabetes
COMPLETED400 Analytics
PHASE3COMPLETED
Efficacy of Lapaquistat Acetate in Subjects Currently Treated With Lipid-Lowering Therapy.
Type 2 DiabetesUnlock trial analytics

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
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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.
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about Lapaquistat and lipid-lowering therapy

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.