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

NCT00461968 | Completed DMC

• 1 other identifier: 072004-28
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholesterol, LDL

Keywords

Cholesterol; LDL; Ezetimibe; Statin; Zetia; Zocor; Simvastin

Outcome Measures

Primary Outcomes (2)

• 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.

Interventions

Ezetimibe and Simvastatin DRUG

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator
• Donald W. Reynolds Foundation: collaborator

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Ezetimibe; Simvastatin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Helen H Hobbs, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: February 1, 2005
• Study Completion: April 1, 2007
• Last Updated: April 18, 2007

Record last verified: 2007-04

Locations

US (1)