Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED) - Full Text View

Purpose

The purpose of this study is to assess the cholesterol lowering safety and effectiveness of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Condition	Intervention	Phase
Hypercholesterolemia Hypertriglyceridemia	Drug: MK0653, ezetimibe Drug: Comparator: fenofibrate monotherapy	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment
Official Title:	Evaluation of the Efficacy and Safety of Fenofibrate and Ezetimibe Coadministration in Patients With Mixed Hyperlipidemia

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis

MedlinePlus related topics: Cholesterol Triglycerides

Drug Information available for: Fenofibrate Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Tolerability

Secondary Outcome Measures:

Plasma LDL-C, HDL-C and triglycerides after 12 weeks.

Estimated Enrollment:	600
Study Start Date:	January 2003
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Detailed Description:

The duration of treatment is 48 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

High cholesterol and high triglycerides

Exclusion Criteria:

Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092573

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Farnier M, Freeman MW, Macdonell G, Perevozskaya I, Davies MJ, Mitchel YB, Gumbiner B; the Ezetimibe Study Group. Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia. Eur Heart J. 2005 May;26(9):897-905. Epub 2005 Mar 21.

McKenney JM, Farnier M, Lo KW, Bays HE, Perevozkaya I, Carlson G, Davies MJ, Mitchel YB, Gumbiner B. Safety and efficacy of long-term co-administration of fenofibrate and ezetimibe in patients with mixed hyperlipidemia. J Am Coll Cardiol. 2006 Apr 18;47(8):1584-7. Epub 2006 Mar 30.

Tribble DL, Farnier M, Macdonell G, Perevozskaya I, Davies MJ, Gumbiner B, Musliner TA. Effects of fenofibrate and ezetimibe, both as monotherapy and in coadministration, on cholesterol mass within lipoprotein subfractions and low-density lipoprotein peak particle size in patients with mixed hyperlipidemia. Metabolism. 2008 Jun;57(6):796-801.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Farnier M, Dong Q, Shah A, Johnson-Levonas AO, Brudi P. Low incidence of paradoxical reductions in HDL-C levels in dyslipidemic patients treated with fenofibrate alone or in combination with ezetimibe or ezetimibe/simvastatin. Lipids Health Dis. 2011 Nov 16;10:212.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00092573 History of Changes
Other Study ID Numbers:	2004_036, MK0653-036
Study First Received:	September 23, 2004
Last Updated:	May 24, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Mixed hyperlipidemia (high cholesterol and high triglycerides)

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Hyperlipidemia, Familial Combined
Hypertriglyceridemia
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn

Fenofibrate
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Anticholesteremic Agents

ClinicalTrials.gov processed this record on June 18, 2013