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Completed

NCT Number: NCT01483950

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

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.

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Key information

Conditions

Hypercholesterolaemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Banja Luka, Bosnia and Herzegovina

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 2, 2011
Registry last updated
Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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