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

Completed

• Conditions: Dyslipidemia
• Interventions: Behavioral: Patient Compliance

• Registration Number: NCT00673660
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-07
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2010-10-06
• Results First Submitted QC: 2010-10-06
• Results First Posted: 2010-11-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Statins	Patient Compliance	Patients with dyslipidemia who are taking or planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin or generics).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Were Compliant With Statin Treatment	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 Outcome Measures

Name	Time	Method
Number of Participants With Reasons of Compliance to Statin Treatment	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.
Number of Participants With Reasons of Non-compliance to Statin Treatment	Month 12	Participants were called for a final visit and reasons for non-compliance were recorded.
Available Lipid Profiles of Compliant and Non-compliant Participants	Month 12	Available laboratory measurements of participants were recorded in CRFs.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇹🇷 Istanbul, Turkey