Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377) - Full Text View

Sponsor:	Schering-Plough
Collaborator:	Merck
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00650663

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia Atherosclerosis	Drug: Ezetimibe + Simvastatin Drug: Simvastatin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Atherosclerosis Cholesterol

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Percent change in LDL-C from baseline to endpoint. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline to endpoint in TC, TG, HDL-C, non-HDL-C, and ApoB. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment:	247
Study Start Date:	October 2003
Study Completion Date:	September 2004
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ezetimibe + Simvastatin	Drug: Ezetimibe + Simvastatin oral tablets; ezetimibe 10 mg and simvastatin 20 mg once daily for 12 weeks Other Name: SCH 58235
Active Comparator: Simvastatin	Drug: Simvastatin oral tablet; simvastatin 20 mg once daily for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00650663 History of Changes
Other Study ID Numbers:	P03377
Study First Received:	March 31, 2008
Last Updated:	March 31, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Atherosclerosis
Hypercholesterolemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin

Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012