Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia (0653-152)(COMPLETED)
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ClinicalTrials.gov Identifier: NCT00652847 |
Recruitment Status
:
Completed
First Posted
: April 4, 2008
Last Update Posted
: March 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolemia | Drug: ezetimibe Drug: statins | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | May 2007 |
Actual Study Completion Date : | May 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: group 1
group 1: ezetimibe 10 mg per day is added to actual statin regimen for 6 weeks followed by an observational phase of 6 months.
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Drug: ezetimibe
ezetimibe 10 mg/day for a six week course of treatment.
Other Names:
Drug: statins
patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase
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Active Comparator: Group 2
Group 2: patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase.
|
Drug: statins
patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase
|
- The primary measure of efficacy will be the percent change in plasma LDL-cholesterol between baseline and the final study assessment after six weeks of treatment. [ Time Frame: 6 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients With A Diagnosis Of Primary Hypercholesterolemia And
- Who Are Defined As Being "High Risk" (10-Year Risk Of Coronary Artery Disease > 20 % Based On The Framingham Model Or History Of Diabetes Mellitus Or Any Atherosclerosis Disease)
- And Have Not Reached Their Recommended Ldl-C Target Levels Of 2.5 Mmol/L While On A Statin Alone
Exclusion Criteria:

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): NCT00652847
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Study Data/Documents: CSR Synopsi Link

Publications of Results:
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00652847 History of Changes |
Other Study ID Numbers: |
0653-152 MK0653-152 2008_005 |
First Posted: | April 4, 2008 Key Record Dates |
Last Update Posted: | March 13, 2017 |
Last Verified: | March 2017 |
Additional relevant MeSH terms:
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Ezetimibe |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents |