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

NCT ID: NCT01483950

Last Updated: 2013-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolaemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with hypercholesterolaemia

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vesna Loza, DOC. DR. SCI. MED

Role: PRINCIPAL_INVESTIGATOR

Klinika za bolesti srca i reumatizma Sarajevo , Bosnia and Herzegovina

Meta Jeras, MR PH

Role: STUDY_DIRECTOR

West Balkan MD

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Banja Luka, , Bosnia and Herzegovina

Site Status

Research Site

Bijeljina, , Bosnia and Herzegovina

Site Status

Research Site

Doboj, , Bosnia and Herzegovina

Site Status

Reserach Site

Gradiška, , Bosnia and Herzegovina

Site Status

Research Site

Kakanj, , Bosnia and Herzegovina

Site Status

Research Site

Maglaj, , Bosnia and Herzegovina

Site Status

Research Site

Prijedor, , Bosnia and Herzegovina

Site Status

Research Site

Sarajevo, , Bosnia and Herzegovina

Site Status

Research Site

Tešanj, , Bosnia and Herzegovina

Site Status

Research Site

Trebinje, , Bosnia and Herzegovina

Site Status

Research Site

Visoko, , Bosnia and Herzegovina

Site Status

Research Site

Zavidovići, , Bosnia and Herzegovina

Site Status

Research Site

Zenica, , Bosnia and Herzegovina

Site Status

Research Site

Zvornik, , Bosnia and Herzegovina

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bosnia and Herzegovina

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIS-CBA-CRE-2011/1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.