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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00762229
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : June 14, 2013
Last Update Posted : June 14, 2013
Sponsor:
Information provided by (Responsible Party):
Lawrence Baruch, Bronx VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Ezetimibe 10 mg Drug: Ezetimibe 5 mg Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Prospective Evaluation of LDL Levels in Patients Converted From Zetia (Ezetimibe)10 mg to 5 mg
Study Start Date : July 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008


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 Name: 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 Name: Zetia




Primary Outcome Measures :
  1. LDL Cholesterol [ Time Frame: 4 weeks ]
    LDL cholesterol


Secondary Outcome Measures :
  1. Total Cholesterol [ Time Frame: 4 weeks ]
    Total cholesterol fasting



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762229


Locations
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United States, New York
Bronx VA Medical Center
Bronx, New York, United States, 10468
Sponsors and Collaborators
Bronx VA Medical Center
Investigators
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Principal Investigator: Lawrence Baruch, MD Bronx VA Medical Center
Publications of Results:
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Responsible Party: Lawrence Baruch, Staff physician, Bronx VA Medical Center
ClinicalTrials.gov Identifier: NCT00762229    
Other Study ID Numbers: VA---19-07-051
First Posted: September 30, 2008    Key Record Dates
Results First Posted: June 14, 2013
Last Update Posted: June 14, 2013
Last Verified: June 2013
Keywords provided by Lawrence Baruch, Bronx VA Medical Center:
Cholesterol
Ezetimibe
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents