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

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

375

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bolu, Turkey
        • Pfizer Investigational Site
      • Haseki/Istanbul, Turkey, 34390
        • Pfizer Investigational Site
      • Istanbul, Turkey
        • Pfizer Investigational Site
      • Istanbul, Turkey, 34098
        • Pfizer Investigational Site
    • Istanbul
      • Mecidiyekoy, Istanbul, Turkey, 34394
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Statins
Patients with dyslipidemia who are taking or planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin or generics).
Behavioral: Patient Compliance
Compliance of patients to statin treatment and reasons of compliance or non compliance will be obtained by Patient Reported Outcomes (PROs) every 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Available Lipid Profiles of Compliant and Non-compliant Participants
Time Frame: Month 12
Available laboratory measurements of participants were recorded in CRFs.
Month 12
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.
Month 12
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.
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

May 1, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2581156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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