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

Hypercholesterolaemia Clinical Trial

Official title:

Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors in Bosnia and Herzegovina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483950
• Other study ID #: NIS-CBA-CRE-2011/1
• Status: Completed
• Phase: N/A
• First received: November 30, 2011
• Last updated: February 4, 2013
• Start date: April 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bosnia and Herzegovina: Agency for Medicinal Rroduct and Medicinal Devices of Bosnia and Herzegovina (Clinical Trial Board)
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypercholesterolaemia
• Hypercholesterolemia

Locations

Country	Name	City	State
Bosnia and Herzegovina	Research Site	Banja Luka
Bosnia and Herzegovina	Research Site	Bijeljina
Bosnia and Herzegovina	Research Site	Doboj
Bosnia and Herzegovina	Reserach Site	Gradiška
Bosnia and Herzegovina	Research Site	Kakanj
Bosnia and Herzegovina	Research Site	Maglaj
Bosnia and Herzegovina	Research Site	Prijedor
Bosnia and Herzegovina	Research Site	Sarajevo
Bosnia and Herzegovina	Research Site	Tešanj
Bosnia and Herzegovina	Research Site	Trebinje
Bosnia and Herzegovina	Research Site	Visoko
Bosnia and Herzegovina	Research Site	Zavidovici
Bosnia and Herzegovina	Research Site	Zenica
Bosnia and Herzegovina	Research Site	Zvornik

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No