Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)

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ClinicalTrials.gov Identifier: NCT00652444

Recruitment Status : Completed

First Posted : April 3, 2008

Last Update Posted : January 22, 2016

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: ezetimibe Drug: simvastatin Drug: Placebo (Unspecified)	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
Study Start Date :	September 2003
Actual Primary Completion Date :	August 2004
Actual Study Completion Date :	August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholesterol Medicines

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 Coadministration arm: simvastatin 20mg and ezetimibe 10mg	Drug: ezetimibe ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6. Other Names: Zetia® EZETROL® MK0653 Drug: simvastatin simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6. Other Names: Zocor® MK0733
Experimental: 2 Monotherapy arm: simvastatin 20mg and ezetimibe placebo	Drug: simvastatin simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6. Other Names: Zocor® MK0733 Drug: Placebo (Unspecified) Matching ezetimibe placebo

Outcome Measures

Primary Outcome Measures :

Percentage reduction of LDL-C after 6 weeks of treatment. [ Time Frame: 6 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with known Coronary Artery Disease (CAD) and primary hypercholesterolemia, who are being treated with simvastatin 20mg. Simvastatin consumption meant that subjects must be currently taking simvastatin 20mg daily, and by history have taken at least 80% of daily evening doses for the preceding 6 weeks prior to baseline visit
Age of at least 18 years and 75 years or less
Calculated LDL-C concentration of at least 2.6 and 4.1mmol/l or less using the Friedewald equation, and triglyceride of less than 3.99 mmol/l

Exclusion Criteria:

Congestive heart failure (defined as New York Heart Association class III or IV heart failure)
Uncontrolled cardiac arrhythmias
Acute coronary syndrome, coronary bypass surgery or coronary angioplasty within 3 months of study entry
History of unstable or severe peripheral artery disease within 3 months of study entry
Uncontrolled hypertension at study entry
Uncontrolled or newly diagnosed diabetes mellitus (within 3 months of study entry)
Uncontrolled endocrine or metabolic diseases known to influence serum lipids and lipoproteins; known impairment of renal function
Active or chronic hepatic and hepatobiliary disease
Disorders that would limit study evaluation or 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): NCT00652444

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

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Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications:

Zubaid M, Shakir DK, Bazargani N, Binbrek A, Gopal R, Al-Tamimi O, Bakir S. Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. J Cardiovasc Med (Hagerstown). 2008 Jul;9(7):688-93. doi: 10.2459/JCM.0b013e3282f3a1b1.

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Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00652444
Other Study ID Numbers:	0653-151 2008_004
First Posted:	April 3, 2008 Key Record Dates
Last Update Posted:	January 22, 2016
Last Verified:	January 2016

Additional relevant MeSH terms:

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Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Simvastatin Ezetimibe	Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

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