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

Arm | Intervention/treatment |
---|---|
Experimental: 1
Coadministration arm: simvastatin 20mg and ezetimibe 10mg
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Drug: ezetimibe
ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.
Other Names:
Drug: simvastatin simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
Other Names:
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Experimental: 2
Monotherapy arm: simvastatin 20mg and ezetimibe placebo
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Drug: simvastatin
simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
Other Names:
Drug: Placebo (Unspecified) Matching ezetimibe placebo |
- Percentage reduction of LDL-C after 6 weeks of treatment. [ Time Frame: 6 weeks ]

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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 |
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

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
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
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 |
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 |