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NCT01206231 Clinical Trial

An Epidemiological Study Aimed to Record Standard Daily Practice in Managing Patients With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:
An Epidemiological Study Aimed to Record Standard Daily Practice in Managing Patients With Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01206231
Other study ID # NIS-CRS-DUM-2010/1
Secondary ID
Status Completed
Phase N/A
First received September 20, 2010
Last updated November 7, 2011
Start date December 2010
Est. completion date October 2011

Study information
Verified date November 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Serbia: Clinical Center of Serbia
Study type Observational

Clinical Trial Summary

This study is aimed to collect the following Serbia-specific epidemiology data on hypercholesterolemia: patents characteristics, patients' management/treatment and physicians' standard practice. In addition, the aim is to determine the proportion of patients on lipid-lowering pharmacological treatment who have reached the LDL-C and HDL-C treatment goals.

Recruitment information / eligibility
Status Completed
Enrollment 330
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with hypercholesterolemia currently receiving a lipid lowering agent

Exclusion Criteria:

- Pregnancy and lactation.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Serbia Research Site Belgrade
Serbia Research Site Cacak
Serbia Research Site Kragujevac
Serbia Research Site Nis
Serbia Research Site Niska Banja
Serbia Research Site Pancevo
Serbia Research Site Pozarevac
Serbia Research Site Sombor
Serbia Research Site Sremska Kamenica
Serbia Research Site Uzice

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Serbia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines 24 weeks No
Secondary Proportion of patients on lipid-lowering pharmacological treatment reaching the non HDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines; 24 weeks No
Secondary Physicians' standard practice in managing patients with hypercholesterolemia (by using physicians' questionnaire); 24 weeks No
Secondary Local epidemiological date on patients with hypercholesterolemia (Demographic Data; Hypercholesterolemia management data: treatment, treatment changes) 24 weeks No
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