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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00726856
First received: July 30, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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 Intervention
Dyslipidemia
Drug: Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Evaluation of the change in LDL-C levels after treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Assessment of patient compliance by evaluating the length of stay on therapy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Comparison of the patient comorbidities among populations gathered from different levels of hospitals and specialties [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Evaluation of safety and tolerability in patients receiving dual inhibition therapy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1200
Study Start Date: May 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

Retrospective medical chart review

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00726856     History of Changes
Other Study ID Numbers: P05171
Study First Received: July 30, 2008
Last Updated: July 30, 2008
Health Authority: Taiwan: Department of Health (DOH)

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

ClinicalTrials.gov processed this record on April 23, 2014