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NCT00673660 Clinical Trial

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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00673660
Other study ID # A2581156
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2007
Est. completion date October 2009

Study information
Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 375
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Turkey Pfizer Investigational Site Bolu
Turkey Pfizer Investigational Site Haseki/Istanbul
Turkey Pfizer Investigational Site Istanbul
Turkey Pfizer Investigational Site Istanbul
Turkey Pfizer Investigational Site Mecidiyekoy Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants Who Were Compliant With Statin Treatment 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 Available Lipid Profiles of Compliant and Non-compliant Participants Available laboratory measurements of participants were recorded in CRFs. Month 12
Secondary Number of Participants With Reasons of Compliance to Statin Treatment 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
Secondary Number of Participants With Reasons of Non-compliance to Statin Treatment Participants were called for a final visit and reasons for non-compliance were recorded. Month 12
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