A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)(COMPLETED) - Full Text View

Purpose

The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).

Condition	Intervention	Phase
Hypercholesterolemia	Drug: MK0653A, ezetimibe (+) simvastatin Drug: Comparators: simvastatin and ezetimibe	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

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 LDL-C, TG and HDL-C. The proportion of patients achieving LDL-C targets. Tolerability.

Estimated Enrollment:	1500
Study Start Date:	September 2002
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Detailed Description:

The duration of treatment is 4 months.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

High cholesterol

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: NCT00092651

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Bays HE, Ose L, Fraser N, Tribble DL, Quinto K, Reyes R, Johnson-Levonas AO, Sapre A, Donahue SR; Ezetimibe Study Group. A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia. Clin Ther. 2004 Nov;26(11):1758-73.

Ose L, Shah A, Davies MJ, Rotonda J, Maccubbin D, Tribble D, Veltri E, Mitchel Y. Consistency of lipid-altering effects of ezetimibe/simvastatin across gender, race, age, baseline low density lipoprotein cholesterol levels, and coronary heart disease status: results of a pooled retrospective analysis. Curr Med Res Opin. 2006 May;22(5):823-35.

Feldman T, Davidson M, Shah A, Maccubbin D, Meehan A, Zakson M, Tribble D, Veltri E, Mitchel Y. Comparison of the lipid-modifying efficacy and safety profiles of ezetimibe coadministered with simvastatin in older versus younger patients with primary hypercholesterolemia: a post Hoc analysis of subpopulations from three pooled clinical trials. Clin Ther. 2006 Jun;28(6):849-59.

Feldman T, Ose L, Shah A, Zakson M, Meehan A, Johnson-Levonas AO, Maccubbin D, Tribble DL, Veltri E, Mitchel Y. Efficacy and safety of ezetimibe/simvastatin versus simvastatin monotherapy in hypercholesterolemic patients with metabolic syndrome. Metab Syndr Relat Disord. 2007 Spring;5(1):13-21.

Ose L, Reyes R, Johnson-Levonas AO, Sapre A, Tribble DL, Musliner T. Effects of ezetimibe/simvastatin on lipoprotein subfractions in patients with primary hypercholesterolemia: an exploratory analysis of archived samples using two commercially available techniques. Clin Ther. 2007 Nov;29(11):2419-32.

Pearson T, Ballantyne C, Sisk C, Shah A, Veltri E, Maccubbin D. Comparison of effects of ezetimibe/simvastatin versus simvastatin versus atorvastatin in reducing C-reactive protein and low-density lipoprotein cholesterol levels. Am J Cardiol. 2007 Jun 15;99(12):1706-1713. Epub 2007 May 2.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00092651 History of Changes
Other Study ID Numbers:	2004_048, MK0653A-038
Study First Received:	September 23, 2004
Last Updated:	May 24, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Primary hypercholesterolemia

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Ezetimibe
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013