Study of Undertreatment of Patients With Dyslipidemia in Bulgaria (CEPHEUS)

September 9, 2010 updated by: AstraZeneca

Centralized Pan-Bulgarian Survey on the Undertreatment of Hypercholesterolemia

The purpose of this study is to establish the proportion of Bulgarian patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Fourth Joint European Task Force guidelines.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Blagoevgrad, Bulgaria
        • Research Site
      • Burgas, Bulgaria
        • Research Site
      • Haskovo, Bulgaria
        • Research Site
      • Montana, Bulgaria
        • Research Site
      • Pazardjik, Bulgaria
        • Research Site
      • Pleven, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Russe, Bulgaria
        • Research Site
      • Shumen, Bulgaria
        • Research Site
      • Sliven, Bulgaria
        • Research Site
      • Smolyan, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Stara Zagora, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
      • Veliko Turnovo, Bulgaria
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • Lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks
  • Signed Informed Consent

Exclusion Criteria:

  • Informed Consent not provided

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients with dyslipidemia on lipid lowering therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number and percentage of patients achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines
Time Frame: 6 months - one visit only, no follow-up visits
6 months - one visit only, no follow-up visits

Secondary Outcome Measures

Outcome Measure
Time Frame
The number and percentage of subjects achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines for several subject subsets
Time Frame: 6 months - one visit only, no follow-up visits
6 months - one visit only, no follow-up visits
The number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III / 2004 updated 2004 NCEP ATP III guidelines, overall and for several subject subsets
Time Frame: 6 months - one visit only, no follow-up visits
6 months - one visit only, no follow-up visits
The number and percentage of subjects achieving the non HDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III/national guidelines [<130mg/dL (3,37mmol/L)], in the following sub-population: patients with fasting triglycerides >200 mg/dL
Time Frame: 6 months - one visit only, no follow-up visits
6 months - one visit only, no follow-up visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

February 19, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 25, 2010

Study Record Updates

Last Update Posted (Estimate)

September 10, 2010

Last Update Submitted That Met QC Criteria

September 9, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CBG-CRE-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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