A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol. The primary hypothesis is that treatment with ezetimibe 10 mg/day reduces the cholesterol concentration of the chylomicron-containing Sf≥400 fraction following a cholesterol-enriched test meal.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, 2-Period, Crossover Study to Evaluate the Effects of Ezetimibe on the Postprandial Lipoprotein Response in Patients With Primary Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: ezetimibe
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients will be otherwise healthy men and women (if not on oral contraceptives or hormone replacement therapy) 18 through 70 years of age with moderately high cholesterol. Exclusion Criteria: Individuals on other lipid-lowering therapy (medicines that lower cholesterol) including statins (within 6 weeks) and fibrates (within 8 weeks) prior to administration of the study drug.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ezetimibe→Placebo<br>After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks. | Drug: ezetimibe<br> <br> * Other names: MK-0653;Drug: Comparator: placebo<br> <br> |
| Experimental: Placebo→ Ezetimibe<br>After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks. | Drug: ezetimibe<br> <br> * Other names: MK-0653;Drug: Comparator: placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal | On each of 2 days prior to the last day of each treatment period, participants consumed 2 large eggs in the evening. On the morning of the final day of each treatment period, fasting participants were given a site-prepared, cholesterol-enriched milkshake that provided 1114 calories of total energy ( 44% of calories from fat,  40% of calories from carbohydrate and  17% of calories from protein) and 504 mg of cholesterol. The milkshake was consumed over a 15-minute period. Plasma samples were collected immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours afterwards for isolation and analysis of lipoprotein fractions. The geometric mean concentration level was calculated using data obtained at all timepoints. | Immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours after test meal on Day 28 of each treatment period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol Concentration of Chylomicron-remnant (Sf 60-400) Subfractions After a Cholesterol-Rich Test Meal | On each of 2 days prior to the last day of each treatment period, participants consumed 2 large eggs in the evening. On the morning of the final day of each treatment period, fasting participants were given a site-prepared, cholesterol-enriched milkshake that provided 1114 calories of total energy ( 44% of calories from fat,  40% of calories from carbohydrate and  17% of calories from protein) and 504 mg of cholesterol. The milkshake was consumed over a 15-minute period. Plasma samples were collected immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours afterwards for isolation and analysis of lipoprotein subfractions. The geometric mean concentration level was calculated using data obtained at all timepoints. | Immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours after test meal on Day 28 of each treatment period. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Hypercholesterolemia