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Clinical Trials/NCT00762229
NCT00762229
Completed
Not Applicable

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

Bronx VA Medical Center1 site in 1 country39 target enrollmentJuly 2007
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ConditionsHypercholesterolemia
InterventionsEzetimibe 10 mgEzetimibe 5 mg
DrugsEzetimibe 10 mgEzetimibe 5 mg

Overview

Phase
Not Applicable
Intervention
Ezetimibe 10 mg
Conditions
Hypercholesterolemia
Sponsor
Bronx VA Medical Center
Enrollment
39
Locations
1
Primary Endpoint
LDL Cholesterol
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2007
End Date
September 2008
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bronx VA Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Lawrence Baruch

Staff physician

Bronx VA Medical Center

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

Arms & Interventions

Ezetimibe 10 mg

A whole ezetimibe 10 mg tablet

Intervention: Ezetimibe 10 mg

Ezetimibe 5 mg

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

Intervention: Ezetimibe 5 mg

Outcomes

Primary Outcomes

LDL Cholesterol

Time Frame: 4 weeks

LDL cholesterol

Secondary Outcomes

  • Total Cholesterol(4 weeks)

Study Sites (1)

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