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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 58
- Primary Endpoint
- Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo→ Ezetimibe
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.
Intervention: ezetimibe (Drug)
Ezetimibe→Placebo
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.
Intervention: ezetimibe (Drug)
Outcomes
Primary Outcomes
Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal
Time Frame: 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.
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.
Secondary Outcomes
- Total Cholesterol Concentration of Chylomicron-remnant (Sf 60-400) Subfractions After a Cholesterol-Rich Test Meal(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.)