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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726856
• Other study ID #: P05171
• Status: Completed
• Start date: May 2007
• Est. completion date: July 2007

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Retrospective medical chart review

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate
Ezetimibe 10 mg taken daily for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the change in LDL-C levels after treatment		3 months
Secondary	Assessment of the percentage of patients who attain their National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III target for LDL-C		3 months
Secondary	Assessment of patient compliance by evaluating the length of stay on therapy		3 months
Secondary	Comparison of the patient comorbidities among populations gathered from different levels of hospitals and specialties		3 months
Secondary	Evaluation of safety and tolerability in patients receiving dual inhibition therapy		3 months