Trial Outcomes & Findings for 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) (NCT NCT00101439)
NCT ID: NCT00101439
Last Updated: 2024-06-18
Results Overview
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.
COMPLETED
PHASE3
58 participants
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.
2024-06-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 1
STARTED
|
28
|
30
|
|
Period 1
COMPLETED
|
28
|
30
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
28
|
30
|
|
Period 2
COMPLETED
|
28
|
28
|
|
Period 2
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 2
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Ezetimibe→Placebo
n=28 Participants
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.
|
Placebo→ Ezetimibe
n=30 Participants
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.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 8.84 • n=5 Participants
|
48.4 years
STANDARD_DEVIATION 9.48 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: Participants who received at least one dose of study drug and did not have any protocol violations.
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.
Outcome measures
| Measure |
Ezetimibe
n=56 Participants
Participants who received ezetimibe 10 mg in active treatment period regardless of randomly assigned sequence
|
Placebo
n=56 Participants
Participants who received placebo in active treatment period regardless of randomly assigned sequence
|
|---|---|---|
|
Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal
|
0.45 mg/dL
Interval 0.1 to 2.82
|
0.50 mg/dL
Interval 0.02 to 1.9
|
SECONDARY outcome
Timeframe: 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.Population: Participants who received at least one dose of study drug and did not have any protocol violations.
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 subfractions. The geometric mean concentration level was calculated using data obtained at all timepoints.
Outcome measures
| Measure |
Ezetimibe
n=56 Participants
Participants who received ezetimibe 10 mg in active treatment period regardless of randomly assigned sequence
|
Placebo
n=56 Participants
Participants who received placebo in active treatment period regardless of randomly assigned sequence
|
|---|---|---|
|
Total Cholesterol Concentration of Chylomicron-remnant (Sf 60-400) Subfractions After a Cholesterol-Rich Test Meal
|
4.87 mg/dL
Interval 1.25 to 23.74
|
4.78 mg/dL
Interval 0.93 to 31.36
|
Adverse Events
Ezetimibe
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER