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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762229
• Other study ID #: VA---19-07-051
• Status: Completed
• Phase: N/A
• First received: September 29, 2008
• Last updated: June 12, 2013
• Start date: July 2007
• Est. completion date: September 2008

Study information

• Verified date: June 2013
• Source: Bronx VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Ezetimibe 10 mg
Ezetimibe 10 mg daily for 4 weeks
• Ezetimibe 5 mg
Ezetimibe 5 mg daily for 4 weeks, "formulated" as a 10 mg tablet split in half

Locations

Country	Name	City	State
United States	Bronx VA Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bronx VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL Cholesterol	LDL cholesterol	4 weeks	No
Secondary	Total Cholesterol	Total cholesterol fasting	4 weeks	No