Evaluation of Low-Density Lipoprotein (LDL) Cholesterol Levels in Patients Switched From Zetia 10 Milligrams to 5 Milligrams - Full Text View

Sponsored by:	Bronx VA Medical Center
Information provided by:	Bronx VA Medical Center
ClinicalTrials.gov Identifier:	NCT00762229

Purpose

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	Intervention
Hypercholesterolemia	Drug: Ezetimibe 10 mg Drug: Ezetimibe 5 mg

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Ezetimibe Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Prospective Evaluation of LDL Levels in Patients Converted From Zetia 10 mg to 5 mg

Further study details as provided by Bronx VA Medical Center:

Primary Outcome Measures:

LDL cholesterol [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total cholesterol [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	July 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Ezetimibe 10 mg: Active Comparator A whole ezetimibe 10 mg tablet	Drug: Ezetimibe 10 mg Ezetimibe 10 mg daily for 4 weeks
Ezetimibe 5 mg: Experimental 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762229

Locations

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

Sponsors and Collaborators

Bronx VA Medical Center

More Information

Responsible Party:	Bronx VA Medical Center ( Lawrence Baruch )
Study ID Numbers:	VA---19-07-051
Study First Received:	September 29, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00762229
Health Authority:	United States: Federal Government

Keywords provided by Bronx VA Medical Center:

Cholesterol
Ezetimibe

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Ezetimibe
Metabolic disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Anticholesteremic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009