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

Phase 3

Terminated

• Conditions: Hypercholesterolemia, Familial

• Registration Number: NCT00384293
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-03
• Study First Submitted QC: 2006-10-05
• Study First Posted: 2006-10-06
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-07-23
• Results First Submitted QC: 2009-07-23
• Results First Posted: 2009-09-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 937

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Lipid Profile	after 96 weeks of postrandomization treatment