Status:
TERMINATED
Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hypercholesterolemia, Familial
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 o...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
937 Patients enrolled
Trial Details
Trial ID
NCT00384293
Start Date
September 1 2006
End Date
August 1 2008
Last Update
September 30 2015
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