Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)

Study Overview
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Brief Summary
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This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima media thickening using ultrasound compared to patients taking placebo. There will be 12 scheduled clinic visits involving review of medical history, physical exam, vital signs, laboratory testing, ultrasound imaging, and electrocardiograms.

Official Title
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A Worldwide, Double-Blind, Randomized, Placebo-Controlled Study of MK0524A 2g Coadministered With Intensive LDL-C Lowering Therapy Compared to Intensive LDL-C Lowering Therapy Alone on Carotid Artery Intima Media Thickening (cIMT) in Patients With Heterozygous Familial Hypercholesterolemia (heFH)

Conditions
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Hypercholesterolemia, Familial

Intervention / Treatment
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* Drug: Comparator: niacin (+) laropiprant (MK0524A)
* Drug: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are 18 to 70 years of age with Heterozygous Familial Hypercholesterolemia and a LDL-C greater than or equal to 100mg/dL and triglycerides less than or equal to 400mg/dL at Visit 1 while on a stable dose of intensive LDL-C lowering therapy Exclusion Criteria: A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study Patients with less than 80% drug study compliance Patients with chronic medical conditions known to influence serum lipids or lipoproteins or significantly affect the ultrasound acoustic window Patients with unstable dose of medications Pregnant or lactating women, or women intending to become pregnant are excluded Patient with diabetes mellitus that is poorly controlled, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin) Patients with the following conditions: high grade stenosis (greater than 75%) of the carotid artery, chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, episode of gout (within 1 year)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MK0524A | Drug: Comparator: niacin (+) laropiprant (MK0524A)<br>* niacin (+) laropiprant (2 g) po qd.<br>* Other names: MK0524A;|
| Placebo Comparator: 2<br>placebo | Drug: Comparator: placebo<br>* niacin (+) laropiprant (2 g) placebo po qd.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Carotid Intima Media Thickness | change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery. | after 96 weeks of postrandomization treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lipid Profile |  | after 96 weeks of postrandomization treatment |