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

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ClinicalTrials.gov Identifier: NCT01075594
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : September 10, 2010
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease
Dyslipidemia

Study Type : Observational
Actual Enrollment : 2500 participants
Time Perspective: Prospective
Official Title: Centralized Pan-Bulgarian Survey on the Undertreatment of Hypercholesterolemia
Study Start Date : February 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Group/Cohort
1
Patients with dyslipidemia on lipid lowering therapy



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Biospecimen Retention:   None Retained
whole blood, serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075594


Locations
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, Bulgaria
Sponsors and Collaborators
AstraZeneca

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01075594     History of Changes
Other Study ID Numbers: NIS-CBG-CRE-2009/1
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: September 10, 2010
Last Verified: September 2010

Keywords provided by AstraZeneca:
Dyslipidemia
Target cholesterol
Undertreatment

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases