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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00726856 |
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Date of registration:
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30/07/2008 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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A Retrospective Survey to Evaluate the Effectiveness and Safety of Dual Inhibition Lipid-Lowering Regimen in the Treatment of Dyslipidemic Patients in Normal Practice |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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1200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00726856 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dyslipidemia
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Intervention(s)
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Drug: Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate
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Primary Outcome(s)
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Evaluation of the change in LDL-C levels after treatment
[Time Frame: 3 months]
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Secondary Outcome(s)
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Assessment of patient compliance by evaluating the length of stay on therapy
[Time Frame: 3 months]
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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]
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Comparison of the patient comorbidities among populations gathered from different levels of hospitals and specialties
[Time Frame: 3 months]
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Evaluation of safety and tolerability in patients receiving dual inhibition therapy
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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