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Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ezetimibe 10 mg
Ezetimibe 5 mg
Sponsored by
Bronx VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypercholesterolemia focused on measuring Cholesterol, Ezetimibe

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects receiving ezetimibe 10 mg

  • Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%):

    • 90 day prescriptions: Filled a ezetimibe prescription within the previous 4 months
    • 60 day prescriptions: Filled a ezetimibe prescription within the previous 2.5 months
    • 30 day prescriptions: Filled a ezetimibe prescription within the previous 1.5 months
  • Patients willing and able to provide signed informed consent

Exclusion Criteria:

  • Patients not receiving ezetimibe
  • Patients receiving ezetimibe 5 milligrams
  • Patients with a history of being titrated from ezetimibe 5 to 10 mg. Stroke,TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months
  • Cancer undergoing active treatment
  • Participation in any clinical study within the last 30 days
  • Drug addiction or alcohol abuse within the past 6 months
  • Patients unwilling or unable to provide informed consent
  • Patients with poor compliance
  • Women of childbearing potential

Sites / Locations

  • Bronx VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ezetimibe 10 mg

Ezetimibe 5 mg

Arm Description

A whole ezetimibe 10 mg tablet

Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half

Outcomes

Primary Outcome Measures

LDL Cholesterol
LDL cholesterol

Secondary Outcome Measures

Total Cholesterol
Total cholesterol fasting

Full Information

First Posted
September 29, 2008
Last Updated
June 12, 2013
Sponsor
Bronx VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00762229
Brief Title
Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe)
Official Title
Prospective Evaluation of LDL Levels in Patients Converted From Zetia (Ezetimibe)10 mg to 5 mg
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bronx VA Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Cholesterol, Ezetimibe

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ezetimibe 10 mg
Arm Type
Active Comparator
Arm Description
A whole ezetimibe 10 mg tablet
Arm Title
Ezetimibe 5 mg
Arm Type
Experimental
Arm Description
Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half
Intervention Type
Drug
Intervention Name(s)
Ezetimibe 10 mg
Other Intervention Name(s)
Zetia
Intervention Description
Ezetimibe 10 mg daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Ezetimibe 5 mg
Other Intervention Name(s)
Zetia
Intervention Description
Ezetimibe 5 mg daily for 4 weeks, "formulated" as a 10 mg tablet split in half
Primary Outcome Measure Information:
Title
LDL Cholesterol
Description
LDL cholesterol
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Total Cholesterol
Description
Total cholesterol fasting
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects receiving ezetimibe 10 mg Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%): 90 day prescriptions: Filled a ezetimibe prescription within the previous 4 months 60 day prescriptions: Filled a ezetimibe prescription within the previous 2.5 months 30 day prescriptions: Filled a ezetimibe prescription within the previous 1.5 months Patients willing and able to provide signed informed consent Exclusion Criteria: Patients not receiving ezetimibe Patients receiving ezetimibe 5 milligrams Patients with a history of being titrated from ezetimibe 5 to 10 mg. Stroke,TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months Cancer undergoing active treatment Participation in any clinical study within the last 30 days Drug addiction or alcohol abuse within the past 6 months Patients unwilling or unable to provide informed consent Patients with poor compliance Women of childbearing potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Baruch, MD
Organizational Affiliation
Bronx VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronx VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19463517
Citation
Baruch L, Agarwal S, Gupta B, Haynos A, Eng C. Effect on serum lipid levels of switching dose of ezetimibe from 10 to 5 mg. Am J Cardiol. 2009 Jun 1;103(11):1568-71. doi: 10.1016/j.amjcard.2009.01.365. Epub 2009 Apr 22.
Results Reference
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Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe)

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