Fenofibrate

Generic Name
Fenofibrate
Brand Names
Antara, Cholib, Fenoglide, Fenomax, Lipidil Supra, Lipofen, Tricor, Triglide
Drug Type
Small Molecule
Chemical Formula
C20H21ClO4
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
-

Acute and Long-Term Outcome Investigations of Fenofibrate on Severely Burned Patients

First Posted Date
2012-04-10
Last Posted Date
2019-11-29
Lead Sponsor
The University of Texas Medical Branch, Galveston
Target Recruit Count
3
Registration Number
NCT01574131
Locations
🇺🇸

University of Texas Medical Branch, Galveston, Texas, United States

A Clinical Trial to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia

First Posted Date
2012-02-27
Last Posted Date
2013-10-28
Lead Sponsor
Zydus Lifesciences Limited
Target Recruit Count
109
Registration Number
NCT01539616
Locations
🇮🇳

Shree Nidan Hospital, Clinical trial department, First floor, 27-28 Vidhyut nagar-A, Ajmer road, Jaipur, Rajasthan, India

🇮🇳

Gastrocare Clinic,Ground floor, Karansinhji Main Road,, Rajkot, Gujarat, India

🇮🇳

Bhatia Hospital, Tardeo Road,Room no 19, Basement floor,Research room,, Mumbai, Maharashtra, India

and more 15 locations

A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic

First Posted Date
2011-11-01
Last Posted Date
2015-03-17
Lead Sponsor
Abbott
Target Recruit Count
506
Registration Number
NCT01462877
Locations
🇨🇳

Site Reference ID/Investigator# 64695, Xiamen, China

Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate

Phase 2
Completed
Conditions
Interventions
First Posted Date
2011-08-31
Last Posted Date
2016-02-03
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
99
Registration Number
NCT01426438
Locations
🇺🇸

University of Colorado Hospital CRS (6101), Aurora, Colorado, United States

🇺🇸

NY Univ. HIV/AIDS CRS (401), New York, New York, United States

🇺🇸

University of Southern California (1201), Los Angeles, California, United States

and more 11 locations

The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.

First Posted Date
2011-03-22
Last Posted Date
2024-06-05
Lead Sponsor
University of Sydney
Target Recruit Count
450
Registration Number
NCT01320345
Locations
🇦🇺

Mater Adult Hospital, South Brisbane, Queensland, Australia

🇦🇺

Canberra Hospital, Garran, Australian Capital Territory, Australia

🇦🇺

Southern Adelaide Diabetes and Endocrine Services, Oaklands Park, South Australia, Australia

and more 20 locations

Insulin Resistance in Non-alcoholic Fatty Liver Disease

Not Applicable
Terminated
Conditions
Interventions
First Posted Date
2011-02-04
Last Posted Date
2017-08-17
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
11
Registration Number
NCT01289639
Locations
🇺🇸

VA Puget Sound Health Care System, Seattle, Seattle, Washington, United States

The Influence of Ritonavir, Alone and in Combination With Lopinavir, on Fenofibric Acid Pharmacokinetics in Healthy Volunteers

First Posted Date
2010-06-22
Last Posted Date
2019-12-09
Lead Sponsor
National Institutes of Health Clinical Center (CC)
Target Recruit Count
25
Registration Number
NCT01148004
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Pilot Study of Fenofibrate for PSC

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2010-06-11
Last Posted Date
2018-02-06
Lead Sponsor
University of Miami
Target Recruit Count
8
Registration Number
NCT01142323
Locations
🇺🇸

University of Miami, Miami, Florida, United States

🇺🇸

University of Florida, Gainesville, Florida, United States

Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2010-06-10
Last Posted Date
2014-04-02
Lead Sponsor
University of Miami
Registration Number
NCT01141296
Locations
🇺🇸

Mayo Clinic Rochester, Rochester, Minnesota, United States

🇺🇸

University of Miami, Miami, Florida, United States

Effects of Fenofibrate on Gene Expression in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-04-23
Last Posted Date
2010-04-23
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
26
Registration Number
NCT01109758
Locations
🇬🇧

Site 1, London, United Kingdom

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