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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00650663
First received: March 31, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

March 31, 2008
March 31, 2008
October 2003
September 2004   (final data collection date for primary outcome measure)
Percent change in LDL-C from baseline to endpoint. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377)
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Atherosclerosis
  • Drug: Ezetimibe + Simvastatin
    oral tablets; ezetimibe 10 mg and simvastatin 20 mg once daily for 12 weeks
    Other Name: SCH 58235
  • Drug: Simvastatin
    oral tablet; simvastatin 20 mg once daily for 12 weeks
  • Experimental: Ezetimibe + Simvastatin
    Intervention: Drug: Ezetimibe + Simvastatin
  • Active Comparator: Simvastatin
    Intervention: Drug: Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
247
September 2004
September 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00650663
P03377
No
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Schering-Plough
Merck Sharp & Dohme Corp.
Not Provided
Schering-Plough
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP