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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01243255
First Posted: November 18, 2010
Last Update Posted: April 4, 2012
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
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 ]

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 ]
  • 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 ]
  • identify determinants (patient and physician characteristics) for undertreatment of hypercholesterolemia. [ Time Frame: whole study procedure takes place during the one, single patient's visit ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
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): NCT01243255


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01243255     History of Changes
Other Study ID Numbers: NIS-CPL-DUM-2010/1
First Submitted: November 17, 2010
First Posted: November 18, 2010
Last Update Posted: April 4, 2012
Last Verified: April 2012

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

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