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)

Completed Phase 3 Results posted Last updated 18 June 2024

What this trial tests

Phase 3 trial testing ezetimibe in Hypercholesterolemia in 58 participants. Completed in 8 November 2006.

Timeline

10 November 2005

Primary endpoint
24 October 2006

8 November 2006

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	58
Start date	10 November 2005
Primary completion	24 October 2006
Estimated completion	8 November 2006

Drugs / interventions tested

• ezetimibe (EZETIMIBE) — full drug profile →
• Comparator: placebo — full drug profile →

Conditions studied

• Hypercholesterolemia — all drugs for Hypercholesterolemia →

Sponsor

Organon and Co — full company profile →

Who can join

Adults 18 to 70, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal Primary · 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 af

Group	Value	95% CI
Ezetimibe	0.45	0.10 – 2.82
Placebo	0.50	0.02 – 1.90

Total Cholesterol Concentration of Chylomicron-remnant (Sf 60-400) Subfractions After a Cholesterol-Rich Test Meal Secondary · 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 af

Group	Value	95% CI
Ezetimibe	4.87	1.25 – 23.74
Placebo	4.78	0.93 – 31.36

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.