drugset / Trial / NCT00101439

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)

NCT00101439 ↗

Phase 3 Completed 58 enrolled Organon and Co
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2005-11-10
Primary completion
2006-10-24
Completion
2006-11-08

Outcome

Missed primary endpoint

registry analysis (unspecified test); Ezetimibe vs Placebo; p = 0.241; Geometric Mean Ratio (GMR) 0.89 (95% CI 0.73 to 1.08); ANOVA NCT00101439 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg —

Indications