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Completed

NCT Number: NCT00673660

Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels

The purpose of the study is to show the compliance rates of the patients to statin treatment and the reasons of non-compliance.

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Key information

Conditions

Dyslipidemia Behavior Dyslipidemias Health Behavior Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Mecidiyeköy, Istanbul, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with dyslipidemia and taking or planning to take statin treatment.
  • Patients living in the same city of the study center. o Patients aged 18 years and over.

Exclusion criteria

  • Patients with severe systemic disease
  • Patients with alcohol and drug addiction and/or mental disease
  • Patients nursing or pregnant, or planning to get pregnant during the study

Treatment and study plan

Patient Compliance

Behavioral

Compliance of patients to statin treatment and reasons of compliance or non compliance will be obtained by Patient Reported Outcomes (PROs) every 3 months.

Primary outcomes

  1. Percentage of Participants Who Were Compliant With Statin Treatment

    Time frame: Month 12

    The physician asked participants about their compliance with medication use, which was defined as not skipping or forgetting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used.

Secondary outcomes

  1. Available Lipid Profiles of Compliant and Non-compliant Participants

    Time frame: Month 12

    Available laboratory measurements of participants were recorded in CRFs.

  2. Number of Participants With Reasons of Compliance to Statin Treatment

    Time frame: Month 12

    Compliance with medication use defined as not skipping or forgeting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. Participants were called for a final visit . Compliance with drug dosage was recorded.

  3. Number of Participants With Reasons of Non-compliance to Statin Treatment

    Time frame: Month 12

    Participants were called for a final visit and reasons for non-compliance were recorded.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

Assessment Of Statin Treatment Compliance In Dyslipidemia Patients: An Observational Study

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 7, 2008
Registry last updated
Feb 21, 2021

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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