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

This study has been completed.

First Received: March 31, 2008 Last Updated: August 1, 2008 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00652444

Purpose

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

Condition	Intervention	Phase
Hypercholesterolemia	Drug: ezetimibe Drug: simvastatin Drug: Placebo (Unspecified)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percentage reduction of LDL-C after 6 weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	September 2003
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Coadministration arm: simvastatin 20mg and ezetimibe 10mg	Drug: ezetimibe ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6. Drug: simvastatin simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
2: Experimental Monotherapy arm: simvastatin 20mg and ezetimibe placebo	Drug: simvastatin simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6. Drug: Placebo (Unspecified) Matching ezetimibe placebo

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652444

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_004
Study First Received:	March 31, 2008
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00652444 History of Changes
Health Authority:	United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010