Skip to main content
OpenTrials
Completed

NCT Number: NCT00762229

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bronx VA Medical Center

The Bronx, New York, 10468, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ezetimibe 10 mg

Drug

Ezetimibe 10 mg daily for 4 weeks

Other names: Zetia

Ezetimibe 5 mg

Drug

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

Other names: Zetia

Primary outcomes

  1. LDL Cholesterol

    Time frame: 4 weeks

    LDL cholesterol

Secondary outcomes

  1. Total Cholesterol

    Time frame: 4 weeks

    Total cholesterol fasting

Sponsors and collaborators

Lead sponsor

Bronx VA Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 30, 2008
Registry last updated
Jun 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.