Polish Survey on the Efficacy of the Hypercholesterolemia Treatment

Hypercholesterolemia Clinical Trial

— CEPHEUS  

Official title:

Centralized Pan-European Survey on the Undertreatment of Hypercholesterolemia. Polish Survey on the Efficacy of the Hypercholesterolemia Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243255
• Other study ID #: NIS-CPL-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: November 17, 2010
• Last updated: April 3, 2012
• Start date: December 2010
• Est. completion date: June 2011

Study information

• Verified date: April 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypercholesterolemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	establish the proportion of patients on lipid lowering pharmacological treatment reaching the LDL-C goals according to ESC 2007 guidelines in general.		whole study procedure takes place during the one, single patient's visit	No
Secondary	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		whole study procedure takes place during the one, single patient's visit	No
Secondary	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		whole study procedure takes place during the one, single patient's visit	No
Secondary	identify determinants (patient and physician characteristics) for undertreatment of hypercholesterolemia.		whole study procedure takes place during the one, single patient's visit	No