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

NCT00726856 | Completed

• 1 other identifier: P05171
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Evaluation of the change in LDL-C levels after treatment

  3 months

Secondary Outcomes (4)

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

  3 months

• Assessment of patient compliance by evaluating the length of stay on therapy

  3 months

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

  3 months

• Evaluation of safety and tolerability in patients receiving dual inhibition therapy

  3 months

Study Arms (1)

Patients

patients with dyslipidemia

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

Interventions

Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate DRUG

Ezetimibe 10 mg taken daily for 3 months

Also known as: SCH 58235

Patients

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Dyslipidemias

Interventions

Ezetimibe; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Fenofibrate

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 1, 2008
• Study Start: May 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: February 16, 2022

Record last verified: 2022-02