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

Sponsor:	University of Texas Southwestern Medical Center
Collaborators:	Merck Donald W. Reynolds Foundation
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00461968

Purpose

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	Intervention
Cholesterol, LDL	Drug: Ezetimibe and Simvastatin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

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

Estimated Enrollment:	240
Study Start Date:	February 2005
Study Completion Date:	April 2007

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Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Donald W. Reynolds Foundation

Investigators

Principal Investigator:

Helen H Hobbs, MD

UT Southwestern Medical Center

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00461968 History of Changes
Other Study ID Numbers:	072004-28
Study First Received:	April 17, 2007
Last Updated:	April 17, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

Cholesterol
LDL
Ezetimibe
Statin

Zetia
Zocor
Simvastin

Additional relevant MeSH terms:

Simvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
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 February 09, 2012