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Comparison of Efficacy and Safety of Ezetimibe or Statin Monotherapy to Co-Administration of Both

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ClinicalTrials.gov Identifier: NCT00461968
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : April 18, 2007
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to compare the percent change in LDL cholesterol induced by ezetimibe or simvastatin monotherapy and by co-administration of both agents in Black, White and Hispanic men. Ezetimibe is a drug that blocks sterol absorption and simvastatin blocks hepatic cholesterol biosynthesis. The hypothesis to be tested is that Blacks are likely to be more responsive to LDL lowering by ezetimibe than statins because Blacks have a low production of cholesterol.

Condition or disease Intervention/treatment
Cholesterol, LDL Drug: Ezetimibe and Simvastatin

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Genetic Determinanats of Cardiovascular Risk Factors: Comparison of Efficacy and Safety of Ezetimibe or Statin Monotherapy to Co-Administration of Both
Study Start Date : February 2005
Study Completion Date : April 2007


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. The primary endpoints of the study will be the percent change in plasma LDL-C concentrations in response to each agent.
  2. The treatment effect for each individual will be the percent reduction achieved with each agent.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Black, white and hispanic males between the ages of 20 to 70 years
  • In good general health
  • Having a body mass index (BMI) between 20 and 35 kg/m2
  • Plasma LDL-C concentrations greater than or equal to 130 mg/dl but less than or equal to 175 mg/dL
  • TG (triglyceride) levels less than or equal to 250 mg/dL.

Exclusion Criteria:

  • Any condition that would be likely to render the individual unable to complete the study
  • Hypersensitivity to HMG-CoA reductase inhibitors
  • Poor mental function, drug or substance abuse, or unstable psychiatric illnesses that may interfere with optimal participation in the study
  • Treatment with another investigational drug within 30 days prior to Visit 1
  • Alcohol consumption >14 drinks per week
  • Phytosterol/phytostanol-containing products including margarines within 2 weeks
  • History of CHD, peripheral vascular disease, cerebrovascular disease, CHF, or uncontrolled arrhythmias
  • Creatinine >1.5 mg/dL, nephrotic syndrome, or other renal disease
  • Fasting plasma glucose (FPG) >126 mg/dL or history of diabetes
  • Abnormal TSH
  • Uncontrolled hypertension (systolic BP >160 mm Hg and/or diastolic BP >100 mm Hg)
  • Known active liver diseases or elevated serum transaminases (ALT and AST >1.5 times the upper limit of normal)
  • Digestive disorders or any abdominal surgery within the past 6 months
  • Cancer within the past 5 years (except for skin cancer)
  • HIV, HBV, or HCV positive
  • Lipid-lowering agents: bile-acid binding resins, HMG-CoA reductase inhibitors, ezetimibe, niacin (>200 mg/day), cholestin, fish oil, and fibrates, or cholesterol absorption inhibitors (e.g., neomycin) taken within 8 weeks prior to Visit 1
  • Medications that are potent inhibitors of CYP3A4 (cyclosporine, systemic itraconazole or ketoconazole, erythromycin or clarithromycin, nefazodone, verapamil, amiodarone, and protease inhibitors)
  • Anti-obesity medications: orlistat or sibutramine taken within 8 weeks prior to Visit 1
  • Systemic corticosteroids.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461968


Locations
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Merck Sharp & Dohme Corp.
Donald W. Reynolds Foundation
Investigators
Principal Investigator: Helen H Hobbs, MD UT Southwestern Medical Center
More Information

ClinicalTrials.gov Identifier: NCT00461968     History of Changes
Other Study ID Numbers: 072004-28
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: April 18, 2007
Last Verified: April 2007

Keywords provided by University of Texas Southwestern Medical Center:
Cholesterol
LDL
Ezetimibe
Statin
Zetia
Zocor
Simvastin

Additional relevant MeSH terms:
Simvastatin
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors