Status:
COMPLETED
Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hypercholesterolemia
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate whether coadministration of ezetimibe 10 mg/day with simvastatin 20 mg/day for 12 weeks will result in greater reduction of LDL-C, total cholesterol (TC), trig...
Eligibility Criteria
Inclusion
- Adult African-American or Black subjects with diagnosis of primary hypercholesterolemia with plasma LDL-C \>=145 mg/dL and \<=250 mg/dL, and plasma TG \<=350 mg/dL
- Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable HRT or raloxifene regimen for at least 6 weeks and throughout the study
- Female subjects of non-childbearing potential
- Willingness to give written consent, participate and complete all study-related procedures, and ability to follow a stable NCEP Step I (or stricter) diet regimen and keep a diet diary when required.
- Clinical laboratory tests (CBC, blood chemistries, and urinalysis) within normal limits (except as noted below) or clinically acceptable.
- ALT (SGPT) and AST (SGOT) concentrations \<=2 times the upper limit of normal (ULN) and creatine phosphokinase \<=2 times the ULN.
Exclusion
- Pregnancy or any other situation, condition, or illness that, in the opinion of the investigator, may interfere with optimal participation in the study
- Secondary forms of hyperlipidemia or underlying disease likely to limit life span to less than one year
- Known hypersensitivity or any contraindication to simvastatin or ezetimibe
- Use of investigational drugs within 30 days of study entry
- Concomitant illnesses: congestive heart failure NYHA Class III or IV; obstructive cardiomyopathy; uncontrolled cardiac arrhythmias; severe aortic stenosis; MI, CABG or angioplasty within 3 months of study; unstable or severe peripheral artery disease; unstable angina pectoris; study-limiting disorders of the hematologic, digestive or central nervous systems including cerebrovascular disease and degenerative disease; uncontrolled or newly diagnosed diabetes mellitus; uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (clinically euthyroid subjects on stable replacement doses of thyroid hormone are eligible for enrollment); uncontrolled hypertension; known impairment of renal function (plasma creatinine \>2.0 mg/dL), dysproteinemia, nephrotic syndrome or other renal disease (24-hour urinary protein 3+ or 1 gram); hepatobiliary or hepatic disease (AST or ALT \>2 times the upper limit of the reference range); HIV positive; known coagulopathy.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT00650663
Start Date
October 1 2003
End Date
September 1 2004
Last Update
August 15 2024
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