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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206231
First Posted: September 21, 2010
Last Update Posted: November 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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:


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 ]

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 ]
  • Physicians' standard practice in managing patients with hypercholesterolemia (by using physicians' questionnaire); [ Time Frame: 24 weeks ]
  • Local epidemiological date on patients with hypercholesterolemia (Demographic Data; Hypercholesterolemia management data: treatment, treatment changes) [ Time Frame: 24 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206231


Locations
Serbia
Research Site
Belgrade, Serbia
Research Site
Cacak, Serbia
Research Site
Kragujevac, Serbia
Research Site
Niska Banja, Serbia
Research Site
Nis, 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01206231     History of Changes
Other Study ID Numbers: NIS-CRS-DUM-2010/1
First Submitted: September 20, 2010
First Posted: September 21, 2010
Last Update Posted: November 8, 2011
Last Verified: November 2011

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

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