Polish Survey on the Efficacy of the Hypercholesterolemia Treatment

NCT01243255 | Completed

• 1 other identifier: NIS-CPL-DUM-2010/1
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypercholesterolemia

Keywords

hypercholesterolemia; low density lipoprotein; undertreatment of hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• 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

• identify determinants (patient and physician characteristics) for undertreatment of hypercholesterolemia.

  whole study procedure takes place during the one, single patient's visit

Study Arms (1)

1

Patients with hypercholesterolemia on lipid lowering pharmacological treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Prof. Artur Mamcarz

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Barbara Możejko-Pastewka

  AstraZeneca Pharma

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 18, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 4, 2012

Record last verified: 2012-04