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

NCT00650663 | Completed Phase 4

• 1 other identifier: P03377
• Study Type: interventional
• Target: 247
• Locations: 0 countries
• Sites: N/A

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), 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.

Conditions

Hypercholesterolemia; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Percent change in LDL-C from baseline to endpoint.

  Week 12

Secondary Outcomes (1)

• Percent change from baseline to endpoint in TC, TG, HDL-C, non-HDL-C, and ApoB.

  Week 12

Study Arms (2)

Ezetimibe + Simvastatin

EXPERIMENTAL

Drug: Ezetimibe + Simvastatin

Simvastatin

ACTIVE COMPARATOR

Drug: Simvastatin

Interventions

Ezetimibe + Simvastatin DRUG

oral tablets; ezetimibe 10 mg and simvastatin 20 mg once daily for 12 weeks

Also known as: SCH 58235

Ezetimibe + Simvastatin

Simvastatin DRUG

oral tablet; simvastatin 20 mg once daily for 12 weeks

Simvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (1)

• Rodney RA, Sugimoto D, Wagman B, Zieve F, Kerzner B, Strony J, Yang B, Suresh R, Veltri E. Efficacy and safety of coadministration of ezetimibe and simvastatin in African-American patients with primary hypercholesterolemia. J Natl Med Assoc. 2006 May;98(5):772-8.

  PMID: 16749654 RESULT

MeSH Terms

Conditions

Hypercholesterolemia; Atherosclerosis

Interventions

Ezetimibe, Simvastatin Drug Combination; Ezetimibe; Simvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: October 1, 2003
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: August 15, 2024

Record last verified: 2022-02