A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00093899

Purpose

The purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Condition	Intervention	Phase
Hyperlipidemia Hypercholesterolemia Hypertriglyceridemia	Drug: ezetimibe (+) simvastatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Fenofibrate 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 hypercholesterolemia primary carnitine deficiency

MedlinePlus related topics: Cholesterol Triglycerides

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Plasma LDL-C.

Secondary Outcome Measures:

Plasma HDL-C, non-HDL-C, and TG. Tolerability

Estimated Enrollment:	600
Study Start Date:	December 2004

Intervention Details:

Duration of Treatment: 6 months

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women 18-79 years of age with high cholesterol and high triglycerides.

Exclusion Criteria:

Individuals who do not meet specific cholesterol or triglyceride levels as required by the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093899

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Farnier M, Roth E, Gil-Extremera B, Mendez GF, Macdonell G, Hamlin C, Perevozskaya I, Davies MJ, Kush D, Mitchel YB; Ezetimibe/Simvastatin + Fenofibrate Study Group. Efficacy and safety of the coadministration of ezetimibe/simvastatin with fenofibrate in patients with mixed hyperlipidemia. Am Heart J. 2007 Feb;153(2):335.e1-8.

Farnier M, Perevozskaya I, Taggart WV, Kush D, Mitchel YB. VAP II analysis of lipoprotein subclasses in mixed hyperlipidemic patients on treatment with ezetimibe/simvastatin and fenofibrate. J Lipid Res. 2008 Jul 31; [Epub ahead of print]

Gil-Extremera B, Mendez G, Zakson M, Meehan A, Shah A, Lin J, Mitchel Y. Efficacy and safety of ezetimibe/simvastatin co- administered with fenofibrate in mixed hyperlipidemic patients with metabolic syndrome. Metab Syndr Relat Disord. 2007 Dec;5(4):305-14.

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_044, MK0653A-071
Study First Received:	October 7, 2004
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00093899 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Mixed Hyperlipidemia

Additional relevant MeSH terms:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Hypertriglyceridemia
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Therapeutic Uses
Hyperlipidemia, Familial Combined
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010