Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia; Atherosclerosis
Intervention: Ezetimibe + Simvastatin (Drug); Simvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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), triglycerides (TG), non HDL-C, and apolipoprotein B (ApoB), and greater
increase in HDL-C, compared with simvastatin 20 mg/day as monotherapy for 12 weeks in
African-American subjects with primary hypercholesterolemia. This study is being performed
to better define the efficacy of ezetimibe coadministered with simvastatin in this
population.
Clinical Details
Official title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Lipid-Altering Efficacy, Safety, and Tolerability of Ezetimibe Coadministered With Simvastatin Versus Simvastatin Monotherapy in African-American Subjects With Primary Hypercholesterolemia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percent change in LDL-C from baseline to endpoint.
Secondary outcome: Percent change from baseline to endpoint in TC, TG, HDL-C, non-HDL-C, and ApoB.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Additional Information
Starting date: October 2003
Last updated: April 7, 2015
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