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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-C

Assessment 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

Page last updated: August 23, 2015

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