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Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment

NCT00819403 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-01-14

Study results available
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Summary

To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.

Conditions

  • Metabolic Syndrome

Interventions

DRUG

simvastatin

Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.

DRUG

ezetimibe/simvastatin

Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.

Sponsors & Collaborators

Principal Investigators

  • MICHAEL MILLER, MD · University of Maryland, College Park

  • VICTOR L. Serebruany, MD, PhD · President, HeartDrug Research LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00819403 on ClinicalTrials.gov