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Completed

NCT Number: NCT00726856

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

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

Retrospective medical chart review

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate

Drug

Ezetimibe 10 mg taken daily for 3 months

Other names: SCH 58235

Primary outcomes

  1. Evaluation of the change in LDL-C levels after treatment

    Time frame: 3 months

Secondary outcomes

  1. Assessment of the percentage of patients who attain their National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III target for LDL-C

    Time frame: 3 months

  2. Assessment of patient compliance by evaluating the length of stay on therapy

    Time frame: 3 months

  3. Comparison of the patient comorbidities among populations gathered from different levels of hospitals and specialties

    Time frame: 3 months

  4. Evaluation of safety and tolerability in patients receiving dual inhibition therapy

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 1, 2008
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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