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Fluvastatin

Generic Name
Fluvastatin
Brand Names
Lescol
Drug Type
Small Molecule
Chemical Formula
C24H26FNO4
CAS Number
93957-54-1
Unique Ingredient Identifier
4L066368AS
Background

Fluvastatin is an antilipemic agent that competitively inhibits hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase. HMG-CoA reductase catalyzes the conversion of HMG-CoA to mevalonic acid, the rate-limiting step in cholesterol biosynthesis. Fluvastatin belongs to a class of medications called statins and is used to reduce plasma cholesterol levels and prevent cardiovascular disease. It is also the first entirely synthetic HMG-CoA reductase inhibitor and is structurally distinct from the fungal derivatives of this therapeutic class. Fluvastatin is a racemate comprising equimolar amounts of (3R,5S)- and (3S,5R)-fluvastatin.

Indication

To be used as an adjunct to dietary therapy to prevent cardiovascular events. May be used as secondary prevention in patients with coronary heart disease (CHD) to reduce the risk of requiring coronary revascularization procedures, for reducing progression of coronary atherosclerosis in hypercholesterolemic patients with CHD, and for the treatment of primary hypercholesterolemia and mixed dyslidipidemia.

Associated Conditions
Atherosclerosis, Heterozygous Familial Hypercholesterolemia (HeFH), Mixed Dyslipidemias, Primary Hypercholesterolemia, Revascularization procedures

Statins in Proteinuric Nephropathies

Phase 3
Completed
Conditions
Chronic Nephropathy
Proteinuria
Hypertension
Interventions
Drug: standard therapy
First Posted Date
2005-09-20
Last Posted Date
2010-04-28
Lead Sponsor
Mario Negri Institute for Pharmacological Research
Target Recruit Count
217
Registration Number
NCT00199927
Locations
🇮🇹

Clinical Research Center for Rare Diseases, Ranica, Bergamo, Italy

🇮🇹

Hospital "Casa Sollievo della Sofferenza" - Unit of Nephrology and Dialysis, San Giovanni Rotondo, Foggia, Italy

🇮🇹

Hospital "S.Giacomo Apostolo", Castelfranco Veneto, Treviso, Italy

and more 13 locations

Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Phase 4
Completed
Conditions
Dyslipidemia
First Posted Date
2005-09-15
Last Posted Date
2017-02-23
Lead Sponsor
Novartis
Target Recruit Count
120
Registration Number
NCT00171262
Locations
🇪🇸

Novartis, Madrid, Spain

Efficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction

Phase 4
Completed
Conditions
Hypertension
Dyslipidemia
First Posted Date
2005-09-15
Last Posted Date
2011-11-08
Lead Sponsor
Novartis
Target Recruit Count
213
Registration Number
NCT00171327
Locations
🇷🇺

Novartis, Moscow, Russian Federation

Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

Phase 3
Completed
Conditions
Heterozygous Familial Hypercholesterolemia
Mixed Dyslipidemia
First Posted Date
2005-09-15
Last Posted Date
2011-11-08
Lead Sponsor
Novartis
Target Recruit Count
84
Registration Number
NCT00171236
Locations
🇨🇭

Novartis, Basel, Switzerland

Statin Therapy in Asymptomatic Aortic Stenosis

Phase 2
Conditions
Aortic Valve Stenosis
First Posted Date
2005-09-15
Last Posted Date
2010-01-14
Lead Sponsor
University of Leipzig
Target Recruit Count
100
Registration Number
NCT00176410
Locations
🇩🇪

University of Leipzig - Heart Center, Leipzig, Saxony, Germany

Fluvastatin in the Therapy of Acute Coronary Syndrome

Phase 4
Completed
Conditions
Coronary Disease
Myocardial Infarction
First Posted Date
2005-09-15
Last Posted Date
2010-07-16
Lead Sponsor
Novartis
Target Recruit Count
1000
Registration Number
NCT00171275
Locations
🇨🇿

Novartis, Praha, Czech Republic

Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome

Phase 4
Completed
Conditions
Metabolic Syndrome
First Posted Date
2005-08-30
Last Posted Date
2017-02-23
Lead Sponsor
Novartis
Target Recruit Count
55
Registration Number
NCT00138528
Locations
🇩🇪

Novartis, Nürnberg, Germany

Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia

Phase 3
Completed
Conditions
Mixed Dyslipidemia
Hypercholesterolemia
First Posted Date
2005-08-29
Last Posted Date
2017-02-23
Lead Sponsor
Novartis
Target Recruit Count
325
Registration Number
NCT00136799
Locations
🇨🇳

Novartis, Shangai, China

A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)

Phase 3
Completed
Conditions
Hypercholesterolemia
First Posted Date
2005-08-22
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
450
Registration Number
NCT00132717

Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

Phase 4
Completed
Conditions
Dyslipidemia
First Posted Date
2005-07-29
Last Posted Date
2017-05-17
Lead Sponsor
Novartis
Target Recruit Count
218
Registration Number
NCT00125125
Locations
🇺🇸

Novartis, East Hanover, New Jersey, United States

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