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NCT01075594 Clinical Trial

Study of Undertreatment of Patients With Dyslipidemia in Bulgaria

Dyslipidemia Clinical Trial

— CEPHEUS  

Official title:
Centralized Pan-Bulgarian Survey on the Undertreatment of Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01075594
Other study ID # NIS-CBG-CRE-2009/1
Secondary ID
Status Completed
Phase N/A
First received February 19, 2010
Last updated September 9, 2010
Start date February 2010
Est. completion date August 2010

Study information
Verified date September 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Bulgaria: Bulgarian Drug Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2500
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Bulgaria Research Site 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

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Bulgaria, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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