Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)

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ClinicalTrials.gov Identifier: NCT00092586

Recruitment Status : Completed

First Posted : September 28, 2004

Last Update Posted : February 15, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Organon and Co

Study Description

Brief Summary:

The purpose of this 6-week study is to compare the reduction in specific levels of cholesterol in patients with high cholesterol.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: MK0653, ezetimibe Drug: Comparator: statins	Phase 3

Detailed Description:

The duration of treatment is 6 weeks.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2904 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Multi-center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg/Day When Added to Ongoing Therapy With a Statin Versus Statin Therapy Alone, in Patients With Hypercholesterolemia Who Have Not Reached National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Target LDL-Cholesterol Level
Study Start Date :	September 2002
Actual Primary Completion Date :	October 2003
Actual Study Completion Date :	October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholesterol Cholesterol Levels: What You Need to Know Cholesterol Medicines Statins

Drug Information available for: Ezetimibe

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Percent change in LDL-C

Secondary Outcome Measures :

Percentage of patients reaching NCEP ATP III target LDL-C levels

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

High cholesterol levels that are identified by specific laboratory values

Exclusion Criteria:

Active liver disease
Any condition or situation which would interfere with participation

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092586

Sponsors and Collaborators

Organon and Co

Investigators

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Study Director:	Medical Monitor	Merck Sharp & Dohme LLC

More Information

Study Data/Documents: CSR Synopsis This link exits the ClinicalTrials.gov site

Publications:

Pearson TA, Denke MA, McBride PE, Battisti WP, Brady WE, Palmisano J. A community-based, randomized trial of ezetimibe added to statin therapy to attain NCEP ATP III goals for LDL cholesterol in hypercholesterolemic patients: the ezetimibe add-on to statin for effectiveness (EASE) trial. Mayo Clin Proc. 2005 May;80(5):587-95. doi: 10.4065/80.5.587.

Pearson T, Denke M, McBride P, Battisti WP, Brady WE, Palmisano J. Effectiveness of the addition of ezetimibe to ongoing statin therapy in modifying lipid profiles and attaining low-density lipoprotein cholesterol goals in older and elderly patients: subanalyses of data from a randomized, double-blind, placebo-controlled trial. Am J Geriatr Pharmacother. 2005 Dec;3(4):218-28.

Pearson TA, Denke MA, McBride PE, Battisti WP, Gazzara RA, Brady WE, Palmisano J. Effectiveness of ezetimibe added to ongoing statin therapy in modifying lipid profiles and low-density lipoprotein cholesterol goal attainment in patients of different races and ethnicities: a substudy of the Ezetimibe add-on to statin for effectiveness trial. Mayo Clin Proc. 2006 Sep;81(9):1177-85. doi: 10.4065/81.9.1177.

Denke M, Pearson T, McBride P, Gazzara RA, Brady WE, Tershakovec AM. Ezetimibe added to ongoing statin therapy improves LDL-C goal attainment and lipid profile in patients with diabetes or metabolic syndrome. Diab Vasc Dis Res. 2006 Sep;3(2):93-102. doi: 10.3132/dvdr.2006.020.

Pearson TA, Ballantyne CM, Veltri E, Shah A, Bird S, Lin J, Rosenberg E, Tershakovec AM. Pooled analyses of effects on C-reactive protein and low density lipoprotein cholesterol in placebo-controlled trials of ezetimibe monotherapy or ezetimibe added to baseline statin therapy. Am J Cardiol. 2009 Feb 1;103(3):369-74. doi: 10.1016/j.amjcard.2008.09.090. Epub 2008 Oct 30.

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

Thongtang N, Lin J, Schaefer EJ, Lowe RS, Tomassini JE, Shah AK, Tershakovec AM. Effects of ezetimibe added to statin therapy on markers of cholesterol absorption and synthesis and LDL-C lowering in hyperlipidemic patients. Atherosclerosis. 2012 Dec;225(2):388-96. doi: 10.1016/j.atherosclerosis.2012.09.001. Epub 2012 Sep 13.

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Responsible Party:	Organon and Co
ClinicalTrials.gov Identifier:	NCT00092586
Other Study ID Numbers:	0653-040 2004_037
First Posted:	September 28, 2004 Key Record Dates
Last Update Posted:	February 15, 2022
Last Verified:	February 2022

Additional relevant MeSH terms:

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Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Ezetimibe	Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents

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