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fluvastatin, ezetimibe

Phase 3

Dyslipidemia | Small molecule | Cardiovascular |Novartis AG|Last Updated: Nov 8, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment83

FDA Designations

No designations recorded

Clinical trial landscape

fluvastatin, ezetimibe · 1 trial · 1 indication

Phase 3 1
NCT00171288Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin AloneDyslipidemia
COMPLETED83 Analytics
PHASE3COMPLETED
Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
DyslipidemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Endpoints

Change from baseline in total triglyceride, high density lipoprotein cholesterol, and composition of low density lipoprotein cholesterol after 12 weeks
Change from baseline in circulating marker of inflammation after 12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
fluvastatin, ezetimibeDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients aged 18-75 Primary hypercholesterolemia Signed informed consent Exclusion Criteria: * Patients involved in clinical trials 3 months prior to inclusion Patients treated with drugs specified in protocol Fertile women not using contraceptive methods Other protocol def...

Countries:Spain
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Frequently asked questions about fluvastatin, ezetimibe

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.