Fenofibrate

Generic Name: Fenofibrate

Brand Names: Antara, Cholib, Fenoglide, Fenomax, Lipidil Supra, Lipofen, Tricor, Triglide

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₁ClO_₄

CAS Number: 49562-28-9

Unique Ingredient Identifier: U202363UOS

Background: Fenofibrate is a fibric acid derivative like clofibrate and gemfibrozil. Fenofibrate is used to treat primary hypercholesterolemia, mixed dyslipidemia, severe hypertriglyceridemia.

Fenofibrate was granted FDA approval on 31 December 1993.

Indication: Fenofibrate is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides, and Apo B, and to increase HDL-C adults with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate is also indicated to treat adults with severe hypertriglyceridemia.

Associated Conditions: Mixed Dyslipidemias, Primary Hypercholesterolemia, Severe Hypertriglyceridemia (sHTG), Severe Fredrickson Type IV Hypertriglyceridemia, Severe Fredrickson Type V Hypertriglyceridemia

Associated Therapies: -

Clinical Trials

Predictors of Response to Fenofibrate

Completed

Conditions: Hypertriglyceridemia
Insulin Resistance

Interventions: Drug: Fenofibrate

First Posted Date: 2009-12-02

Last Posted Date: 2015-10-14

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 39

Registration Number: NCT01023750

Locations: 🇺🇸
UAB Kirklin Clinic, Birmingham, Alabama, United States

Treatment of Hyperlipidemia and Sexual Dysfunction

Phase 4

Conditions: Sexual Dysfunction
Hyperlipidemia

Interventions: Drug: fenofibrate + rosuvastatin
Drug: fenofibrate
Drug: Rosuvastatin

First Posted Date: 2009-06-18

Last Posted Date: 2015-11-18

Lead Sponsor: University of Campania "Luigi Vanvitelli"

Target Recruit Count: 300

Registration Number: NCT00923676

Locations: 🇮🇹
Department of Geriatrics and Metabolic Diseases, Naples, Italy

Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome

Not Applicable

Terminated

Conditions: Polycystic Ovary Syndrome

Interventions: Other: Placebo
Drug: Fenofibrate

First Posted Date: 2009-04-21

Last Posted Date: 2015-04-03

Lead Sponsor: Lawson Health Research Institute

Target Recruit Count: 4

Registration Number: NCT00884819

Locations: 🇨🇦
St. Joseph's Health Care, London, Ontario, Canada

The Effect of a Peroxisome Proliferator-activated Receptor (PPAR) Alpha Agonist on Cytochrome P450 (CYP) Monooxygenase Activity in Humans

Phase 4

Completed

Conditions: Hypertension

Interventions: Drug: fenofibrate
Drug: Placebo

First Posted Date: 2009-03-31

Last Posted Date: 2013-06-28

Lead Sponsor: Vanderbilt University

Target Recruit Count: 75

Registration Number: NCT00872599

Locations: 🇺🇸
Vanderbilt University, Nashville, Tennessee, United States

Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients

Phase 4

Conditions: HIV
Hyperlipidemia
HIV Infections

Interventions: Drug: ezetimibe
Drug: pravastatin
Drug: fenofibrate

First Posted Date: 2009-02-13

Last Posted Date: 2011-08-02

Lead Sponsor: Ospedale di Circolo - Fondazione Macchi

Target Recruit Count: 60

Registration Number: NCT00843661

Locations: 🇮🇹
Ospedale di Circolo and Fondazione Macchi, Varese, Italy

Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL)

Phase 4

Terminated

Conditions: Hypertriglyceridemia in Type 4 Hyperlipidemia
Non Diabetic Subjects With Normoglycemia

Interventions: Drug: Placebo (Rosiglitazone)
Drug: Rosiglitazone
Drug: Placebo (Fenofibrate)
Drug: Fenofibrate

First Posted Date: 2009-01-09

Last Posted Date: 2014-04-24

Lead Sponsor: Ahmad Slim

Target Recruit Count: 41

Registration Number: NCT00819910

Locations: 🇺🇸
Brooke Army Medical Center, San Antonio, Texas, United States

Effect of Fenofibrate on Sleep Apnea Syndrome

Phase 2

Terminated

Conditions: Dyslipidemia
Sleep Apnea Syndrome
Overweight
Obesity

Interventions: Drug: Placebo
Drug: Fenofibrate

First Posted Date: 2009-01-05

Last Posted Date: 2009-07-22

Lead Sponsor: Solvay Pharmaceuticals

Target Recruit Count: 34

Registration Number: NCT00816829

Locations: 🇫🇷
Site 1, Paris, France

Effect of Lapaquistat Acetate Combined With Fenofibrate on Blood Cholesterol Levels

Phase 2

Completed

Conditions: Hyperlipidemias

Interventions: Drug: Lapaquistat acetate and fenofibrate
Drug: Fenofibrate

First Posted Date: 2008-12-23

Last Posted Date: 2012-05-24

Lead Sponsor: Takeda

Target Recruit Count: 213

Registration Number: NCT00813527

Effects of Fenofibrate on Adipocytokine Levels In Hypertriglyceridemic Patients

Phase 4

Completed

Conditions: Hypertriglyceridemia

Interventions: Drug: fenofibrate

First Posted Date: 2008-09-03

Last Posted Date: 2008-09-03

Lead Sponsor: Gachon University Gil Medical Center

Registration Number: NCT00745407

Locations: 🇰🇷
Gil Medical Center, Incheon, Korea, Republic of

Mitochondrial Oxidation and Insulin Resistance in Burn Patients Treated With Fenofibrate

Phase 2

Withdrawn

Conditions: Burn

Interventions: Drug: fenofibrate
Drug: placebo

First Posted Date: 2008-08-12

Last Posted Date: 2012-12-11

Lead Sponsor: The University of Texas Medical Branch, Galveston

Registration Number: NCT00732485

Drug Development Updates

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