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)

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Comparator: placebo; Drug: ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00101439

0653-072

2005_001

MK-0653-072

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Ezetimibe→Placebo

Experimental group

Description:

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.

Treatment:

Drug: ezetimibe

Drug: Comparator: placebo

Placebo→ Ezetimibe

Experimental group

Description:

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.

Treatment:

Drug: ezetimibe

Drug: Comparator: placebo