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Retrospective Survey Evaluating the Effectiveness and Safety of Dual Inhibition Lipid-lowering in the Treatment of Dyslipidemia (Study P05171)(COMPLETED)

A Retrospective Survey to Evaluate the Effectiveness and Safety of Dual Inhibition Lipid-lowering Regimen in the Treatment of Dyslipidemic Patients in Normal Practice

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00726856
Enrollment
1200
Registered
2008-08-01
Start date
2007-05-31
Completion date
2007-07-31
Last updated
2022-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Brief 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.

Detailed description

Retrospective medical chart review

Interventions

DRUGEzetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate

Ezetimibe 10 mg taken daily for 3 months

Sponsors

Organon and Co
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Evaluation of the change in LDL-C levels after treatment3 months

Secondary

MeasureTime frame
Assessment of the percentage of patients who attain their National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III target for LDL-C3 months
Assessment of patient compliance by evaluating the length of stay on therapy3 months
Comparison of the patient comorbidities among populations gathered from different levels of hospitals and specialties3 months
Evaluation of safety and tolerability in patients receiving dual inhibition therapy3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026