Status:
COMPLETED
Effects of Ezetimibe on the Absorption of Oxidized Cholesterol
Lead Sponsor:
UCSF Benioff Children's Hospital Oakland
Collaborating Sponsors:
Merck Schering-Plough
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to test the effects of Zetia™ (ezetimibe) 10 milligrams (mg) on the absorption of oxysterol into the blood following a meal containing oxysterol.
Detailed Description
There are a number of cholesterol-lowering drugs available that can lower blood cholesterol to a healthier level. Zetia™ (ezetimibe) 10 mg is available by prescription for the treatment of high choles...
Eligibility Criteria
Inclusion
- Not currently pregnant or lactating and is highly unlikely to conceive
- Body Mass Index (BMI) between 20-30 kilograms per meter squared (kg/m2) inclusive.
- Body weight, as reported by patient, stable (±2 kg) for \>6 weeks
- Plasma low density lipoprotein cholesterol (LDL-C) between 130 and 180 milligrams per deciliter (mg/dL) inclusive. Note: One retest allowed.
- Triglyceride (TG) concentrations ≤150 mg/dL. Note: One retest allowed.
- Fasting blood glucose \<110 mg/dL and hemoglobin A1c (HbA1C) ≤ 6 percent at Visit 1. Note: One retest allowed.
- Liver transaminases (ALT, AST) ≤1.5 x upper limit of normal (ULN) and no active liver disease. Note: One retest allowed.
- Creatine Phosphokinase (CPK) ≤2x ULN. Note: One retest allowed.
- Willingness to maintain a stable diet for the duration of the study.
- Can understand and comply with study procedures and signs a written informed consent.
- Patient is ≥80 precent compliant with dosing during Placebo Run-In Period or, in the opinion of the investigator, is able to maintain ≥80 percent therapy compliance during the active treatment period of the study.
Exclusion
- Lipid-lowering therapy and replacement of this therapy with study medication is considered inappropriate by the investigator.
- Consumes an average of more than 2 alcoholic drinks per day.
- Smokes.
- Currently engages in a vigorous exercise regimen or intensive exercise bouts \>4x per month.
- Treated with any other investigational drug within 30 days of Visit 1.
- Hypersensitivity or intolerance to ezetimibe or any component of this medication.
- Any condition or situation which poses a risk to the patient or interfere with participation in the study.
- Congestive heart failure.
- Uncontrolled cardiac arrhythmias.
- History of myocardial infarction, stroke, or any other clinical manifestation of coronary, cerebral, or peripheral vascular disease.
- Uncontrolled hypertension
- Impaired renal function, nephrotic syndrome or other clinically significant renal disease at Visit 1.
- Active or chronic hepatobiliary or hepatic disease.
- History of irritable bowel syndrome, ileal bypass, gastric bypass or any gastrointestinal disorder/condition associated with malabsorption.
- Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins.
- Type I or Type II diabetes mellitus.
- Disorders of the hematologic, digestive, or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation.
- Human Immunodeficiency Virus (HIV) positive.
- History of cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas).
- History of uncontrolled psychiatric illness or drug/alcohol abuse within the past 5 years. Individuals with psychiatric illness adequately controlled and stable on pharmacotherapy may be enrolled at the discretion of the investigator.
- Lipid-lowering agents taken within 6 weeks and fibrates taken within 8 weeks prior to visit 3.
- Cardiovascular medications are acceptable provided the patient has been on a stable regimen for at least 6 weeks prior to Visit 3 and indicates a willingness to continue the stable regimen for the duration of the study.
- Supplementation with antioxidants beyond a standard multivitamin for the duration of the study.
- Psyllium, other fiber-based laxatives, and/or over the counter (OTC) therapies known to affect serum lipid levels taken within 6 weeks of Visit 3.
- Female patients receiving hormone replacement therapy, any estrogen antagonist/agonist or hormonal contraceptives.
- Treatment with cyclosporine except for ophthalmic indication
- Anti-obesity medications such as orlistat or sibutramine taken within 3 months prior to Visit 1.
- Therapeutic doses of systemic corticosteroids except inhaled steroid therapy (for example, Pulmicort®) maintained on a stable dosing regimen for at least 6 weeks prior to randomization (Visit 3) and throughout the duration of the study
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00794677
Start Date
June 1 2006
End Date
September 1 2008
Last Update
March 9 2021
Active Locations (1)
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1
Cholesterol Research Center
Berkeley, California, United States, 94705