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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01075594

First received: February 19, 2010

Last updated: September 9, 2010

Last verified: September 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	February 19, 2010
Last Updated Date	September 9, 2010
Start Date ^ICMJE	February 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 24, 2010)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01075594 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 24, 2010)	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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Undertreatment of Patients With Dyslipidemia in Bulgaria
Official Title ^ICMJE	Centralized Pan-Bulgarian Survey on the Undertreatment of Hypercholesterolemia
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: None Retained Description: whole blood, serum
Sampling Method	Probability Sample
Study Population	Primary care clinic
Condition ^ICMJE	Dyslipidemia
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	1 Patients with dyslipidemia on lipid lowering therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	2500
Completion Date	August 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Bulgaria

Administrative Information
NCT Number ^ICMJE	NCT01075594
Other Study ID Numbers ^ICMJE	NIS-CBG-CRE-2009/1
Has Data Monitoring Committee	No
Responsible Party	MSD, AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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