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Pitavastatin

Phase 3

Dyslipidemia | Small molecule | Cardiovascular |Elevance Health, Inc.|Last Updated: Jul 5, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment122

FDA Designations

No designations recorded

Clinical trial landscape

Pitavastatin · 1 trial · 2 indications

Phase 3 1
NCT02956590Dyslipidemia of Obesity Intervention in TeensDyslipidemia
COMPLETED122 Analytics
PHASE3COMPLETED
Dyslipidemia of Obesity Intervention in Teens
DyslipidemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity (CDO)
2 years

Pulse wave velocity (PWV)

Secondary Endpoints

the effect of pitavastatin versus placebo on vascular measures in obese adolescents with combined dyslipidemia of obesity (CDO)
2 years
the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity
2 years
the effect of pitavastatin versus placebo on Standard Fasting Lipid Profile (FLP)
2 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PitavastatinACTIVE_COMPARATORStudy Drug
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
PitavastatinDRUGStatin
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range10 Years to 19 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Boys and girls aged 10 to 19 years (with 2-year availability for study participation) * BMI ≥85th percentile (using Centers for Disease Control (CDC) BMI charts) * Fasting lipid profile x2 each with all of the following: * LDL-C \<160 mg/dL and ≥90 mg/dL, and * TG (trigly...

Countries:United StatesCanada
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Frequently asked questions about Pitavastatin

What is Pitavastatin used for?

Pitavastatin is a small molecule drug being studied for the treatment of dyslipidemia, a condition characterized by abnormal levels of lipids in the blood. It is being investigated in the context of obesity-related dyslipidemia in adolescents. The drug is currently in Phase 3 clinical development.

Who makes Pitavastatin?

Pitavastatin is being developed by Elevance Health, Inc., a company traded on the stock exchange under the ticker symbol ELV. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with dyslipidemia.

What phase is Pitavastatin in?

Pitavastatin is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being evaluated for its potential to treat dyslipidemia.

What clinical trials is Pitavastatin in?

Pitavastatin has been studied in a Phase 3 clinical trial with the identifier NCT02956590, titled "Dyslipidemia of Obesity Intervention in Teens." This randomized, double-blind, placebo-controlled trial enrolled 122 participants aged 10 years and older with dyslipidemia and obesity. The trial was conducted in the United States and Canada and has been completed.

How does Pitavastatin work?

Pitavastatin is a small molecule drug. Its mechanism of action involves targeting lipid metabolism to reduce abnormal levels of lipids in the blood. It is being studied for its ability to improve lipid profiles in patients with dyslipidemia, particularly in the context of obesity.

Is Pitavastatin FDA approved?

Pitavastatin is not FDA approved for the indication being studied. It is an investigational drug currently in Phase 3 clinical development. The completed clinical trial has provided data, but the drug has not yet received regulatory approval for the treatment of dyslipidemia.