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

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ClinicalTrials.gov Identifier: NCT00726856
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Dyslipidemia Drug: Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate

Detailed Description:
Retrospective medical chart review

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Retrospective
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 Start Date : May 2007
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients
patients with dyslipidemia
Drug: Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate
Ezetimibe 10 mg taken daily for 3 months
Other Name: SCH 58235



Primary Outcome Measures :
  1. Evaluation of the change in LDL-C levels after treatment [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 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
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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00726856     History of Changes
Other Study ID Numbers: P05171
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents