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

NCT ID: NCT00726856

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2007-07-31

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

Conditions

Dyslipidemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients

patients with dyslipidemia

Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate

Intervention Type: DRUG

Ezetimibe 10 mg taken daily for 3 months

Interventions

Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate

Ezetimibe 10 mg taken daily for 3 months

Intervention Type: DRUG

Other Intervention Names

SCH 58235

Eligibility 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

• Patients who were enrolled in other clinical trial observing specific study procedures which deviates from normal practice will not be included in this study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P05171

Identifier Type: -

Identifier Source: org_study_id