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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01206231
First received: September 20, 2010
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition
Hypercholesterolemia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Epidemiological Study Aimed to Record Standard Daily Practice in Managing Patients With Hypercholesterolemia

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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; [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Physicians' standard practice in managing patients with hypercholesterolemia (by using physicians' questionnaire); [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Local epidemiological date on patients with hypercholesterolemia (Demographic Data; Hypercholesterolemia management data: treatment, treatment changes) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with hypercholesterolemia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Speciality care clinics

Criteria

Inclusion Criteria:

  • Patients with hypercholesterolemia currently receiving a lipid lowering agent

Exclusion Criteria:

  • Pregnancy and lactation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206231

Locations
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, Serbia
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Prof.Dr Miodrag Ostojic Division of Cardiology-Clinical Centre of Serbia-Belgrade
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01206231     History of Changes
Other Study ID Numbers: NIS-CRS-DUM-2010/1
Study First Received: September 20, 2010
Last Updated: November 7, 2011
Health Authority: Serbia: Clinical Center of Serbia

Keywords provided by AstraZeneca:
Standard daily practice in managing patients with hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013