Trial Outcomes & Findings for Effect of Ezetimibe on Flow-mediated Brachial Artery Reactivity in Healthy Subjects (NCT NCT00376246)

NCT ID: NCT00376246

Last Updated: 2020-02-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 28 participants
• Primary outcome timeframe: before food, 3 hours postprandially and 6 hours postprandially
• Results posted on: 2020-02-12

Participant Flow

Participant milestones

Measure	Ezetimibe, Then Placebo Participants first recieved ezetimibe, after a washout period of 2 weeks, they then received a placebo.	Placebo, Then Ezetimibe Participants first recieved a placebo, after a washout period of 2 weeks, they then received ezetimibe.
First Intervention (2 Weeks) STARTED	14	14
First Intervention (2 Weeks) COMPLETED	10	12
First Intervention (2 Weeks) NOT COMPLETED	4	2
Washout (2 Weeks) STARTED	10	12
Washout (2 Weeks) COMPLETED	10	12
Washout (2 Weeks) NOT COMPLETED	0	0
Second Intervention (2 Weeks) STARTED	10	12
Second Intervention (2 Weeks) COMPLETED	10	12
Second Intervention (2 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Ezetimibe, Then Placebo Participants first recieved ezetimibe, after a washout period of 2 weeks, they then received a placebo.	Placebo, Then Ezetimibe Participants first recieved a placebo, after a washout period of 2 weeks, they then received ezetimibe.
First Intervention (2 Weeks) Adverse Event	2	0
First Intervention (2 Weeks) Withdrawal by Subject	1	2
First Intervention (2 Weeks) Lost to Follow-up	1	0

Baseline Characteristics

Effect of Ezetimibe on Flow-mediated Brachial Artery Reactivity in Healthy Subjects

Baseline characteristics by cohort

Measure	All Participants n=22 Participants All subjects were randomized to ezetimibe or placebo, allowed a washout period, and then crossed over to the other arm. The demographic data is presented as all participants because the only data available at this time is the aggregated data and there is no access to the primary source data due to the age of this study.
Age, Continuous	34.7 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: before food, 3 hours postprandially and 6 hours postprandially

Outcome measures

Measure	Placebo n=22 Participants Subjects were randomized to ezetimibe vs. placebo, allowed a washout period, and then crossed over to the other arm.	Ezetimibe n=22 Participants Subjects were randomized to ezetimibe vs. placebo, allowed a washout period, and then crossed over to the other arm.
Percent Change in Flow Mediated Dilation Before Food (0 hour)	12.3 percent change Standard Deviation 4.5	11.6 percent change Standard Deviation 4.3
Percent Change in Flow Mediated Dilation 3 Hours Postprandially	10.9 percent change Standard Deviation 5.5	11.1 percent change Standard Deviation 6.3
Percent Change in Flow Mediated Dilation 6 Hours Postprandially	12.8 percent change Standard Deviation 4.3	13.9 percent change Standard Deviation 6.2

SECONDARY outcome

Timeframe: before food, 3 hours post prandial, 6 hours postprandial

Population: The results are reported for ezetimibe and placebo irrespective of order of administration, (there was a washout period of 4-6)

Outcome measures

Measure	Placebo n=22 Participants Subjects were randomized to ezetimibe vs. placebo, allowed a washout period, and then crossed over to the other arm.	Ezetimibe n=22 Participants Subjects were randomized to ezetimibe vs. placebo, allowed a washout period, and then crossed over to the other arm.
Lipid Profile- Change in LDL(Low Density Lipoprotein) before food (0 hour)	92 mg/dl Standard Deviation 24	102 mg/dl Standard Deviation 30
Lipid Profile- Change in LDL(Low Density Lipoprotein) 3 hour postprandial	89 mg/dl Standard Deviation 22	104 mg/dl Standard Deviation 27
Lipid Profile- Change in LDL(Low Density Lipoprotein) 6 hour postprandial	87 mg/dl Standard Deviation 23	101 mg/dl Standard Deviation 28

Adverse Events

Ezetimibe

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ezetimibe n=28 participants at risk Subjects were randomized to ezetimibe vs. placebo, allowed a washout period, and then crossed over to the other arm.	Placebo n=28 participants at risk Subjects were randomized to ezetimibe vs. placebo, allowed a washout period, and then crossed over to the other arm.
Gastrointestinal disorders Abdominal Discomfort	7.1% 2/28 • Number of events 2 • Through Study Completion (total of 8 weeks)	0.00% 0/28 • Through Study Completion (total of 8 weeks)

Additional Information

Ori Ben-Yehuda, MD

UCSD Medical Center

Phone: 619-543-2814

Email: obenyehuda@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place