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

March 19, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1868

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • 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, Croatia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated by specialist

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
1
Patients with hypercholesterolaemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline
Time Frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Percentage of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline
Time Frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.
Time Frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Number of patients with high cardiovascular risk reaching the LDL-C goals according to the Fourth Joint European Task Force guideline.
Time Frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Number of patients with high cardiovascular risk reaching the total cholesterol goals according to the Fourth Joint European Task Force guideline.
Time Frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Percentage of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.
Time Frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Percentage of patients with high cardiovascular risk reaching the LDL-C goals according to the Fourth Joint European Task Force guideline.
Time Frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Percentage of patients with high cardiovascular risk reaching the total cholesterol goals according to the Fourth Joint European Task Force guideline.
Time Frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Svjetlana Serdar, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 9, 2010

First Posted (Estimate)

December 10, 2010

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CHR-CRE-2010/1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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