N/A
Completed N=39
Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe)
Source: ClinicalTrials.gov NCT00762229 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcomePrimary: LDL Cholesterol — 103; 97 mg/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LDL Cholesterol |
103; 97 | — |
| SECONDARY Total Cholesterol |
180; 167 | — |
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
Data sourced from ClinicalTrials.gov (NCT00762229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.