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

NCT ID: NCT01257971

Last Updated: 2012-03-20

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

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Recruitment Status

COMPLETED

Total Enrollment

1868 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercholesterolaemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Patients with hypercholesterolaemia

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Svjetlana Serdar

Role: STUDY_CHAIR

AstraZeneca

Karin Otter

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Biograd na Moru, , Croatia

Site Status

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Bjelovar, , Croatia

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Crikvenica, , Croatia

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Čakovec, , Croatia

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Dubrovnik, , Croatia

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Gospić, , Croatia

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Karlovac, , Croatia

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Koprivnica, , Croatia

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Krapina, , Croatia

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Krapinske Toplice, , Croatia

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Opatija, , Croatia

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Osijek, , Croatia

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Poreč, , Croatia

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Pula, , Croatia

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Rijeka, , Croatia

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Sisak, , Croatia

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Slavonski Brod, , Croatia

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Split, , Croatia

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Stubičke Toplice, , Croatia

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Umag, , Croatia

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Vinkovci, , Croatia

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Virovitica, , Croatia

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Virovitica- Slatina, , Croatia

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Vukovar, , Croatia

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Zadar, , Croatia

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Zageb, , Croatia

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Zagreb, , Croatia

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Countries

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Croatia

Other Identifiers

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NIS-CHR-CRE-2010/1

Identifier Type: -

Identifier Source: org_study_id

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