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

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by:
ClinicalTrials.gov Identifier:
First received: March 31, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

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
Drug: Ezetimibe + Simvastatin
Drug: Simvastatin
Phase 4

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:

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


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

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.
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  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:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
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 April 15, 2014