Two Investigational Drugs in Patients With Mixed Hyperlipidemia - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092560

Purpose

The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety 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 III

Study Type:	Interventional
Study Design:	Treatment, Safety/Efficacy Study
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 hypercholesterolemia primary carnitine deficiency

MedlinePlus related topics: Cholesterol Triglycerides

Drug Information available for: Procetofen Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Plasma LDL-C vs. fenofibrate for 12 weeks.

Secondary Outcome Measures:

All plasma lipid parameters vs. ezetimibe; all non-LDL lipid parameters vs. fenofobrate; safety and tolerability.

Estimated Enrollment:	600
Study Start Date:	January 2003

Detailed Description:

The duration of treatment is 18 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: NCT00092560

Locations

United States, Pennsylvania
Call for Information
Horsham, Pennsylvania, United States, 19044

Sponsors and Collaborators

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.

Study ID Numbers:	2004_035
Study First Received:	September 23, 2004
Last Updated:	June 2, 2006
ClinicalTrials.gov Identifier:	NCT00092560 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

mixed hyperlipidemia
high cholesterol
high triglycerides

Study placed in the following topic categories:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Hypertriglyceridemia
Metabolic Diseases
Antilipemic Agents
Ezetimibe
Anticholesteremic Agents
Procetofen

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

Additional relevant MeSH terms:

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

Procetofen
Pharmacologic Actions
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Therapeutic Uses
Hyperlipidemia, Familial Combined
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on August 13, 2009