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

February 4, 2013 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

800

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

  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina
        • Research Site
      • Bijeljina, Bosnia and Herzegovina
        • Research Site
      • Doboj, Bosnia and Herzegovina
        • Research Site
      • Gradiška, Bosnia and Herzegovina
        • Reserach 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
      • Zavidovići, Bosnia and Herzegovina
        • Research Site
      • Zenica, Bosnia and Herzegovina
        • Research Site
      • Zvornik, Bosnia and Herzegovina
        • 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, 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 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

Cohorts and Interventions

Group / Cohort
Patients with hypercholesterolaemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number and 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
The number and 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
The number and 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
The number and 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

  • Principal Investigator: Vesna Loza, DOC. DR. SCI. MED, Klinika za bolesti srca i reumatizma Sarajevo , Bosnia and Herzegovina
  • Study Director: Meta Jeras, MR PH, West Balkan MD

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

April 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

November 30, 2011

First Submitted That Met QC Criteria

December 1, 2011

First Posted (Estimate)

December 2, 2011

Study Record Updates

Last Update Posted (Estimate)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CBA-CRE-2011/1

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.

Clinical Trials on Hypercholesterolaemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe