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Lapaquistat

Phase 3

Dyslipidemia | Small molecule | Cardiovascular |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_CONTROLLEDDMC
Total Trials2
Total Enrollment2,491

FDA Designations

No designations recorded

Clinical trial landscape

Lapaquistat · 2 trials · 1 indication

Phase 3 2
NCT00143663Effect of Lapaquistat Acetate on Blood Cholesterol Levels in Subjects With Elevated CholesterolDyslipidemia
COMPLETED361 Analytics
NCT00487994Safety and Efficacy of Lapaquistat Acetate Taken Alone and With Atorvastatin in Subjects With Primary DyslipidemiaDyslipidemia
COMPLETED2,130 Analytics
PHASE3COMPLETED
Effect of Lapaquistat Acetate on Blood Cholesterol Levels in Subjects With Elevated Cholesterol
DyslipidemiaUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of Lapaquistat Acetate Taken Alone and With Atorvastatin in Subjects With Primary Dyslipidemia
DyslipidemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in Low-Density Lipoprotein cholesterol
Week 12 or Final Visit
Lens Opacity Classification System findings
Weeks 24, 48, 72, and 96 or Final Visit
Best corrected visual acuity
Weeks 24, 48, 72, and 96 or Final Visit
Adverse Events
Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 or Final Visit
Clinical Laboratory Tests
Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 or Final Visit
Vital signs (blood pressure and pulse rate) and weight
Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 or Final Visit
12-lead Electrocardiogram
Weeks 48 and 96 or Final Visit
Physical Examination
Weeks 48 and 96 or Final Visit

Secondary Endpoints

Change from Baseline in Calculated Low-Density Lipoprotein cholesterol
Week 12 or Final Visit
Change from Baseline in High-Density Lipoprotein cholesterol
Week 12 or Final Visit
Change from Baseline in the ratio of Low-Density Lipoprotein cholesterol/ High-Density Lipoprotein cholesterol
Week 12 or Final Visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lapaquistat Acetate 100 mg QDEXPERIMENTAL -
Placebo QDPLACEBO_COMPARATOR -
Lapaquistat Acetate 100 mg QD + Atorvastatin 10 mg QDEXPERIMENTAL -
Atorvastatin 10 mg QDACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Lapaquistat AcetateDRUGLapaquistat acetate 100 mg, tablets, orally, once daily for up to 12 weeks
PlaceboDRUGLapaquistat acetate placebo-matching tablets, orally, once daily for up to 12 weeks
Lapaquistat acetate and atorvastatinDRUGLapaquistat acetate 100 mg, tablets, orally, once daily and Atorvastatin 10 mg, capsules, orally, once daily for up to 96 weeks.
AtorvastatinDRUGLapaquistat acetate placebo-matching tablets, orally, once daily and Atorvastatin 10 mg, capsules, orally, once daily for up to 96 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites47

Inclusion Criteria: * Female participants of childbearing potential cannot be been pregnant, lactating and are not planning on becoming pregnant and agrees to use acceptable forms of contraception throughout the course of this study. * Must have a mean low-density lipoprotein cholesterol values bet...

Countries:United StatesArgentinaChileCzechiaEstoniaGermanyHungaryLatviaLithuaniaMexicoNetherlandsPeruPolandRussiaSlovakiaSouth AfricaUnited Kingdom
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Frequently asked questions about Lapaquistat

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.