Polish Survey on the Efficacy of the Hypercholesterolemia Treatment (CEPHEUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01243255
First received: November 17, 2010
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

The purpose of the survey is to evaluate the efficacy of treatment of hypercholesterolemia in Polish patients who are currently on lipid- lowering pharmacological therapy . Efficient treatment is defined as achievement of the LDL cholesterol level goals according to the European Society of Cardiology 2007 guidlines.


Condition
Hypercholesterolemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Centralized Pan-European Survey on the Undertreatment of Hypercholesterolemia. Polish Survey on the Efficacy of the Hypercholesterolemia Treatment

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • establish the proportion of patients on lipid lowering pharmacological treatment reaching the LDL-C goals according to ESC 2007 guidelines in general. [ Time Frame: whole study procedure takes place during the one, single patient's visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • establish the proportion of patients on lipid lowering pharmacological treatment in primary prevention, reaching the LDL-C goals according to ESC 2007 guidelines for this sub-population [ Time Frame: whole study procedure takes place during the one, single patient's visit ] [ Designated as safety issue: No ]
  • establish the proportion of patients on lipid lowering pharmacological treatment in secondary prevention, reaching the LDL-C goals according to ESC 2007 guidelines for this sub-population [ Time Frame: whole study procedure takes place during the one, single patient's visit ] [ Designated as safety issue: No ]
  • identify determinants (patient and physician characteristics) for undertreatment of hypercholesterolemia. [ Time Frame: whole study procedure takes place during the one, single patient's visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 1500
Study Start Date: December 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with hypercholesterolemia on lipid lowering pharmacological treatment

  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

Primary care clinic

Criteria

Inclusion Criteria:

  • Patients on lipid lowering drug treatment
  • Lipid lowering drug treatment lasting at least 3 months
  • No lipid lowering drug/dose change for a minimum 6 weeks prior to enrolment to the study

Exclusion Criteria:

  • Lack of patient's signed informed consent form
  • Lack of the blood sample taken for lipid profile and glucose within 10 days before or after assessment of the patient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243255

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Prof. Artur Mamcarz Medical University of Warsaw
Study Director: Barbara Możejko-Pastewka AstraZeneca Pharma
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01243255     History of Changes
Other Study ID Numbers: NIS-CPL-DUM-2010/1
Study First Received: November 17, 2010
Last Updated: April 3, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by AstraZeneca:
hypercholesterolemia
low density lipoprotein
undertreatment of hypercholesterolemia

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

ClinicalTrials.gov processed this record on August 21, 2014