Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values

Completed

• Conditions: Hypercholesterolaemia

• Registration Number: NCT01483950
• Lead Sponsor: AstraZeneca

Brief Summary

This study is non-interventional study of patients who are treated with any HMGCoA reductase inhibitors (rosuvastatin, simvastatin,atorvastatin and fluvastatin) available in Bosnia and Herzegovina for at least 6 months. Data collection for each patient will take place at a single visit. The investigators will complete Case Report Form (CRF) with patient's demographic, the presence of the factors for high cardiovascular risk, current treatment, cholesterol value as well as with further treatment decision.

Detailed Description

Non-interventional study to assess reaching of cholesterol target values in patients treated with HMG-CoA reductase inhibitors in Bosnia and Herzegovina

Study Timeline

• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-02
• Study Start: 2012-04
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Patients, treated with one HMG-CoA reductase inhibitors for at least 6 months without changing the dose for the last 4 weeks at least
• All patients must sign informed consent form

Exclusion Criteria

• Patients who have not signed the Informed Consent Form
• Patients with contraindication for the treatment with HMG-CoA reductase inhibitors as per SmPC approved in Bosnia and Herzegovina

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number and percentage of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline.	During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

Secondary Outcome Measures

Name	Time	Method
The number and percentage of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.	During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
The number and percentage of patients with high cardiovascular risk reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline.	During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
The number and percentage of patients with high cardiovascular risk reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.	During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

Trial Locations

Locations (2)

Research Site; 🇧🇦 Zvornik, Bosnia and Herzegovina

Reserach Site; 🇧🇦 Gradiška, Bosnia and Herzegovina