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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01483950
Collaborator
(none)
800
Enrollment
14
Locations
9
Duration (Months)
57.1
Patients Per Site
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors in Bosnia and Herzegovina
    Study Start Date :
    Apr 1, 2012
    Actual Primary Completion Date :
    Jan 1, 2013
    Actual Study Completion Date :
    Jan 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with hypercholesterolaemia

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Secondary Outcome Measures

    1. 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]

    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. [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. [During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Banja Luka Bosnia and Herzegovina
    2 Research Site Bijeljina Bosnia and Herzegovina
    3 Research Site Doboj Bosnia and Herzegovina
    4 Reserach Site Gradiška Bosnia and Herzegovina
    5 Research Site Kakanj Bosnia and Herzegovina
    6 Research Site Maglaj Bosnia and Herzegovina
    7 Research Site Prijedor Bosnia and Herzegovina
    8 Research Site Sarajevo Bosnia and Herzegovina
    9 Research Site Tešanj Bosnia and Herzegovina
    10 Research Site Trebinje Bosnia and Herzegovina
    11 Research Site Visoko Bosnia and Herzegovina
    12 Research Site Zavidovići Bosnia and Herzegovina
    13 Research Site Zenica Bosnia and Herzegovina
    14 Research Site Zvornik Bosnia and Herzegovina

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT01483950
    Other Study ID Numbers:
    • NIS-CBA-CRE-2011/1
    First Posted:
    Dec 2, 2011
    Last Update Posted:
    Feb 5, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by AstraZeneca
    Dyslipidemia
    Statins
    Total Cholesterol
    Low density lipoprotein (LDL) cholesterol
    High density lipoprotein (HDL) cholesterol
    Additional relevant MeSH terms:
    Hypercholesterolemia

    Study Results

    No Results Posted as of Feb 5, 2013