Non-interventional Study (NIS) to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors

Hypercholesterolaemia Clinical Trial

Official title:

Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) Reductase Inhibitors in Croatia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257971
• Other study ID #: NIS-CHR-CRE-2010/1
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: March 19, 2012
• Start date: January 2011
• Est. completion date: October 2011

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Health and Social Care
• Study type: Observational

Clinical Trial Summary

This is a multi-centre non-interventional study of patients who are treated with any HMGCoA reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and fluvastatin) for at least 6 months. All HMG-CoA reductase inhibitors must be prescribed in accordance with SmPCs approved in Croatia. Data collection for each patient will take place at a single visit. The investigator will complete a Case Report Form with the patient's demographics, the presence of the factors for high cardiovascular risk, current treatment, cholesterol values as well as with further treatment decision.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1868
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who have been treated with one HMG-CoA reductase inhibitor 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 Croatia.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypercholesterolaemia
• Hypercholesterolemia

Locations

Country	Name	City	State
Croatia	Research Site	Biograd na moru
Croatia	Research Site	Bjelovar
Croatia	Research Site	Cakovec
Croatia	Research Site	Crikvenica
Croatia	Research Site	Dubrovnik
Croatia	Research Site	Gospic
Croatia	Research Site	Karlovac
Croatia	Research Site	Koprivnica
Croatia	Research Site	Krapina
Croatia	Research Site	Krapinske toplice
Croatia	Research Site	Opatija
Croatia	Research Site	Osijek
Croatia	Research Site	Porec
Croatia	Research Site	Pula
Croatia	Research Site	Rijeka
Croatia	Research Site	Sisak
Croatia	Research Site	Slavonski brod
Croatia	Research Site	Split
Croatia	Research Site	Stubicke toplice
Croatia	Research Site	Umag
Croatia	Research Site	Vinkovci
Croatia	Research Site	Virovitica
Croatia	Research Site	Virovitica- Slatina
Croatia	Research Site	Vukovar
Croatia	Research Site	Zadar
Croatia	Research Site	Zageb
Croatia	Research Site	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number 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
Primary	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	Number 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	Number 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	Number 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
Secondary	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	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	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