NCT00376246

Brief Summary

The objective of this study is to show that Ezetimibe will improve endothelial function following high cholesterol meals in healthy subjects by decreasing absorption of cholesterol and thus affecting concentration and composition of remnant-like particles.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
11.9 years until next milestone

Results Posted

Study results publicly available

February 12, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

September 13, 2006

Results QC Date

August 1, 2019

Last Update Submit

February 11, 2020

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Flow Mediated Dilation

    before food, 3 hours postprandially and 6 hours postprandially

Secondary Outcomes (1)

  • Lipid Profile- Change in LDL(Low Density Lipoprotein)

    before food, 3 hours post prandial, 6 hours postprandial

Study Arms (2)

Group 1

OTHER

1st group will receive Ezetimibe for 2 weeks followed by washout (no medication) period for 4 weeks and followed by placebo for 2 weeks.

Drug: Ezetimibe

Group 2

OTHER

2nd group will receive Ezetimibe and placebo in reverse order with interspaced 4-week washout period.

Drug: Ezetimibe

Interventions

EzetimibeDRUG
Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults over 18 yrs of age

You may not qualify if:

  • presence of known metabolic syndrome
  • as history of coronary artery disease
  • hypertension
  • diabetes
  • cardiomyopathy
  • tobacco use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ezetimibe

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Ori Ben-Yehuda, MD
Organization
UCSD Medical Center
obenyehuda@ucsd.edu
619-543-2814

Study Officials

  • Ori Ben-Yehuda, MD

    UCSD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 14, 2006

Study Start

September 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

February 12, 2020

Results First Posted

February 12, 2020

Record last verified: 2020-02