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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Ezetimibe 5 mg; Drug: Ezetimibe 10 mg

• Registration Number: NCT00762229
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Results First Submitted: 2013-04-17
• Status Verified: 2013-06
• Results First Submitted QC: 2013-06-12
• Last Update Submitted: 2013-06-12
• Results First Posted: 2013-06-14
• Last Update Posted: 2013-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ezetimibe 5 mg	Ezetimibe 5 mg	Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half
Ezetimibe 10 mg	Ezetimibe 10 mg	A whole ezetimibe 10 mg tablet

Primary Outcome Measures

Name	Time	Method
LDL Cholesterol	4 weeks	LDL cholesterol

Secondary Outcome Measures

Name	Time	Method
Total Cholesterol	4 weeks	Total cholesterol fasting

Trial Locations

Locations (1)

Bronx VA Medical Center; 🇺🇸 Bronx, New York, United States