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Fluvastatin

Phase 3

Heterozygous Familial Hypercholesterolemia | Small molecule | Cardiovascular |Novartis AG|Last Updated: Feb 23, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

Fluvastatin · 2 trials · 3 indications

Phase 3 2
NCT00136799Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary HypercholesterolemiaMixed Dyslipidemia
COMPLETED325 Analytics
NCT00171236Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial HypercholesterolemiaHeterozygous Familial Hypercholesterolemia
COMPLETED84 Analytics
PHASE3COMPLETED
Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia
Mixed DyslipidemiaUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Endpoints

Percent change from baseline in total cholesterol after 12 weeks
Percent change from baseline in high density lipoprotein cholesterol after 12 weeks
Percent change from baseline in total triglycerides after 12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
FluvastatinDRUG -
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Mixed dyslipidemia * Primary hypercholesterolemia Exclusion Criteria: * Pregnant or lactating women * Age \> 18 years Other protocol-defined inclusion and exclusion criteria may apply.

Countries:ChinaSwitzerland
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Frequently asked questions about Fluvastatin

What is Fluvastatin used for?

Fluvastatin is used for dyslipidemia, mixed dyslipidemia, and heterozygous familial hypercholesterolemia. It is a small molecule being developed by Novartis AG for cardiovascular conditions. It is currently in Phase 3 clinical development and is considered investigational, not yet approved.

What does Fluvastatin target?

Fluvastatin is a statin that works by inhibiting HMG-CoA reductase, the enzyme that controls the rate of cholesterol production in the liver. By blocking this enzyme, it reduces cholesterol synthesis, leading to lower levels of LDL cholesterol and triglycerides in the blood.

Who makes Fluvastatin?

Fluvastatin is developed by Novartis AG, a multinational pharmaceutical company. The company is publicly traded under the ticker symbol NVS on the New York Stock Exchange. Novartis is conducting clinical trials to evaluate the drug's efficacy and safety.

What phase is Fluvastatin in?

Fluvastatin is in Phase 3 clinical development. It is an investigational drug and has not yet received FDA approval. The Phase 3 trials are completed, and the drug is being studied for its effects on lipid levels in patients with various cholesterol disorders.

What clinical trials is Fluvastatin in?

Fluvastatin has been studied in several Phase 3 trials, including NCT00136799 in adults with mixed dyslipidemia or primary hypercholesterolemia, NCT00171236 in children with heterozygous familial hypercholesterolemia, and NCT00171288 comparing fluvastatin plus ezetimibe versus fluvastatin alone. All trials are completed.

Is Fluvastatin the same as Lescol?

Fluvastatin is also known by the brand name Lescol. It is a statin medication used to lower cholesterol. The drug is being developed by Novartis AG and is currently in Phase 3 trials for dyslipidemia and related conditions.