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

June 12, 2013 updated by: Lawrence Baruch, Bronx VA Medical Center

Prospective Evaluation of LDL Levels in Patients Converted From Zetia (Ezetimibe)10 mg to 5 mg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10468
        • Bronx VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ezetimibe 10 mg
A whole ezetimibe 10 mg tablet
Drug: Ezetimibe 10 mg
Ezetimibe 10 mg daily for 4 weeks
Other Names:
  • Zetia
Experimental: Ezetimibe 5 mg
Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half
Drug: Ezetimibe 5 mg
Ezetimibe 5 mg daily for 4 weeks, "formulated" as a 10 mg tablet split in half
Other Names:
  • Zetia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL Cholesterol
Time Frame: 4 weeks
LDL cholesterol
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cholesterol
Time Frame: 4 weeks
Total cholesterol fasting
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bronx VA Medical Center

Investigators

  • Principal Investigator: Lawrence Baruch, MD, Bronx VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 29, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Estimate)

June 14, 2013

Last Update Submitted That Met QC Criteria

June 12, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VA---19-07-051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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