Phase 3 N=58 Randomized Double-blind Treatment

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)

Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT00101439 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal — 0.45; 0.50 mg/dL — p=0.241

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ezetimibe (Drug); Comparator: placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Oct 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal	0.45; 0.50	0.241
SECONDARY Total Cholesterol Concentration of Chylomicron-remnant (Sf 60-400) Subfractions After a Cholesterol-Rich Test Meal	4.87; 4.78	0.812

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00101439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.