Study of Undertreatment of Patients With Dyslipidemia in Bulgaria
CEPHEUS
Centralized Pan-Bulgarian Survey on the Undertreatment of Hypercholesterolemia
1 other identifier
observational
2,500
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2010
Shorter than P25 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 19, 2010
CompletedFirst Posted
Study publicly available on registry
February 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedSeptember 10, 2010
September 1, 2010
6 months
February 19, 2010
September 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number and percentage of patients achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines
6 months - one visit only, no follow-up visits
Secondary Outcomes (3)
The number and percentage of subjects achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines for several subject subsets
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
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
6 months - one visit only, no follow-up visits
Study Arms (1)
1
Patients with dyslipidemia on lipid lowering therapy
Eligibility Criteria
Primary care clinic
You may qualify if:
- Lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks
- Signed Informed Consent
You may not qualify if:
- Informed Consent not provided
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (15)
Research Site
Blagoevgrad, Bulgaria
Research Site
Burgas, Bulgaria
Research Site
Haskovo, Bulgaria
Research Site
Montana, Bulgaria
Research Site
Pazardzhik, Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Rousse, 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 Tarnovo, Bulgaria
Biospecimen
whole blood, serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 19, 2010
First Posted
February 25, 2010
Study Start
February 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
September 10, 2010
Record last verified: 2010-09