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
  Purpose

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
Dyslipidemia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Centralized Pan-Bulgarian Survey on the Undertreatment of Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

whole blood, serum


Enrollment: 2500
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with dyslipidemia on lipid lowering therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01075594     History of Changes
Other Study ID Numbers: NIS-CBG-CRE-2009/1
Study First Received: February 19, 2010
Last Updated: September 9, 2010
Health Authority: Bulgaria: Bulgarian Drug Agency

Keywords provided by AstraZeneca:
Dyslipidemia
Target cholesterol
Undertreatment

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2014