Retrospective Survey Evaluating the Effectiveness and Safety of Dual Inhibition Lipid-lowering in the Treatment of Dyslipidemia (Study P05171)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia
Intervention: Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate (Drug)
Phase: N/A
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
Summary
This retrospective study evaluates the effectiveness and safety of ezetimibe plus statin or
ezetimibe plus fenofibrate in dyslipidemic patients that were treated with these dual
inhibition lipid lowering regimens as part of their normal standard of care. This study
assesses the percentage of patients who achieve LDL-C target goals and also evaluates the
patient compliance to treatment.
Clinical Details
Official title: A Retrospective Survey to Evaluate the Effectiveness and Safety of Dual Inhibition Lipid-lowering Regimen in the Treatment of Dyslipidemic Patients in Normal Practice
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Evaluation of the change in LDL-C levels after treatment
Secondary outcome: Assessment of the percentage of patients who attain their National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III target for LDL-CAssessment of patient compliance by evaluating the length of stay on therapy Comparison of the patient comorbidities among populations gathered from different levels of hospitals and specialties Evaluation of safety and tolerability in patients receiving dual inhibition therapy
Detailed description:
Retrospective medical chart review
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient was > 20 years and < 75 years of age on the index date*
- Patient diagnosed with dyslipidemia who did not respond adequately based on NCEP ATP
III target to previous lipid lowering treatment, and have received dual inhibition
therapy, such as ezetimibe plus statins, ezetimibe plus fenofibrate or ezetimibe
alone, for at least 3 months
- Patient has at least one Total Cholesterol and LDL-C measurements at baseline and 3
months after initiating the dual inhibition therapy.
- Patient has the following records documented in the chart during the data collection
period:
- Medical history and co morbidities (if available)
- Total Cholesterol and LDL-C. test results before and after initiating the dual
inhibition therapy
- Prescription information of lipid-lowering dual inhibition regimens NOTE: *
Index date: the date of initiating dual inhibition therapy
Exclusion Criteria:
- Patients who do not meet all the inclusion criteria will be excluded from this
survey.
- Patients who were enrolled in other clinical trial observing specific study
procedures which deviates from normal practice will not be included in this study.
Locations and Contacts
Additional Information
Starting date: May 2007
Last updated: April 15, 2015
|