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

An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Phase 2

Completed

Conditions: Hypercholesterolaemia

Interventions: Drug: alirocumab SAR236553 (REGN727)
Drug: statins
Drug: ezetimibe
Drug: cholestyramine
Drug: fenofibrate
Drug: omega-3 fatty acids
Drug: nicotinic acid

First Posted Date: 2016-09-07

Last Posted Date: 2019-09-06

Lead Sponsor: Sanofi

Target Recruit Count: 42

Registration Number: NCT02890992

Locations: 🇨🇿
Investigational Site Number 2030002, Zlin, Czechia
🇺🇸
Investigational Site Number 8400005, Charlotte, North Carolina, United States
🇺🇸
Investigational Site Number 8400001, Cincinnati, Ohio, United States

and more 13 locations

Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function

Phase 1

Completed

Conditions: Nonalcoholic Steatohepatitis (NASH)

Interventions: Drug: Firsocostat
Drug: Fenofibrate

First Posted Date: 2016-09-07

Last Posted Date: 2020-12-17

Lead Sponsor: Gilead Sciences

Target Recruit Count: 74

Registration Number: NCT02891408

Randomized Comparative Efficacy and Safety Study of Intermittent Simvastatin and Fenofibrate in Hemodialysis

Phase 4

Completed

Conditions: Fenofibrate/Simvastatin Comparison

Interventions: Drug: Fenofibrate
Drug: Simvastatin

First Posted Date: 2016-09-01

Last Posted Date: 2016-09-05

Lead Sponsor: Cairo University

Target Recruit Count: 60

Registration Number: NCT02886299

Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid

Phase 3

Conditions: Primary Biliary Cirrhosis

Interventions: Drug: Fenofibrate
Drug: UDCA

First Posted Date: 2016-07-06

Last Posted Date: 2022-09-30

Lead Sponsor: Xijing Hospital of Digestive Diseases

Target Recruit Count: 104

Registration Number: NCT02823366

Locations: 🇨🇳
Xijing Hosipital, Xi'an, Shaanxi, China

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Phase 3

Completed

Conditions: Primary Biliary Cirrhosis

Interventions: Drug: Fenofibrate
Drug: UDCA

First Posted Date: 2016-07-06

Last Posted Date: 2023-03-08

Lead Sponsor: Xijing Hospital of Digestive Diseases

Target Recruit Count: 117

Registration Number: NCT02823353

Locations: 🇨🇳
Xijing Hosipital, Xi'an, Shaanxi, China

Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)

Phase 4

Completed

Conditions: Dyslipidemia

Interventions: Drug: Alirocumab
Drug: Statins
Drug: Ezetimibe
Drug: Antihyperglycemic Drug
Drug: Fenofibrate
Drug: Nicotinic acid
Drug: Omega-3 fatty acids

First Posted Date: 2015-12-30

Last Posted Date: 2018-05-01

Lead Sponsor: Sanofi

Target Recruit Count: 413

Registration Number: NCT02642159

Locations: 🇺🇸
Investigational Site Number 840-156, Tustin, California, United States
🇫🇮
Investigational Site Number 246101, Oulu, Finland
🇺🇸
Investigational Site Number 840-118, Los Angeles, California, United States

and more 116 locations

Fenofibrate Treatment in SCI

Phase 2

Completed

Conditions: Spinal Cord Injury
Dyslipidemia

Interventions: Other: No intervention
Drug: Fenofibrate

First Posted Date: 2015-05-27

Last Posted Date: 2019-06-26

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 23

Registration Number: NCT02455336

Locations: 🇺🇸
James J. Peters VA Medical Center, Bronx, NY, Bronx, New York, United States
🇺🇸
Kessler Institute for Rehabilitation, West Orange, New Jersey, United States

Fenofibrate and Propranolol in Burn Patients

Phase 2

Terminated

Conditions: Burn

Interventions: Drug: Fenofibrate
Drug: Placebo
Drug: Propranolol

First Posted Date: 2015-05-22

Last Posted Date: 2019-11-29

Lead Sponsor: The University of Texas Medical Branch, Galveston

Target Recruit Count: 18

Registration Number: NCT02452255

Locations: 🇺🇸
Shriners Hospitals for Children, Galveston, Texas, United States

Evaluate the Efficacy of Fenofibrate on Microalbuminuria

Phase 4

Conditions: Microalbuminuria

Interventions: Drug: fenofibrate

First Posted Date: 2014-12-11

Last Posted Date: 2014-12-11

Lead Sponsor: Beijing Chao Yang Hospital

Target Recruit Count: 200

Registration Number: NCT02314533

Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fed Conditions

Not Applicable

Completed

Conditions: Healthy

Interventions: Drug: ANTARA® (fenofibrate)
Drug: fenofibrate

First Posted Date: 2014-12-03

Last Posted Date: 2014-12-03

Lead Sponsor: Ranbaxy Laboratories Limited

Target Recruit Count: 24

Registration Number: NCT02306902

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