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Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia (CEPHEUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01604733
First received: May 21, 2012
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

Study objective is to evaluate the level of control of hypercholesterolemia in Egypt in patients taking lipid lowering agents for at least 3 months ( with no drug change or dose amendment for a minimum of 6 weeks).


Condition
Hypercholesterolemia

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , overall and by country [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the Third Joint European Task Force guideline, in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Determinants (e.g. patient and physician characteristics , country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Physician characteristics associated with the allocation of treatment regimen. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients on lipid-lowering treatment reaching the non HDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the sub-population patients with fasting triglycerides<200 mg/d [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

blood sample


Enrollment: 1000
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
HYPERCHOLESTEROLEMIC PATIENTS

Detailed Description:

Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community patients

Criteria

Inclusion Criteria:

  • 18 years and above on current lipid lowering drug for at least 3 months with no dose change for a minimum of 6 weeks
  • Subject must provide informed consent and comply with the survey procedures

Exclusion Criteria:

  • Less than 18 years less than 3 months on antidyslipidemic agent Subjects who are unwilling or unable to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604733

Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Mohie E Sherif, MD Ethical committee, Faculty of medicine, Alexandria University
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01604733     History of Changes
Other Study ID Numbers: NIS-EG-CRE-2010/01
Study First Received: May 21, 2012
Last Updated: May 23, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by AstraZeneca:
Multi-Center Survey
patients currently on lipid-lowering pharmacological treatment
level of Control of Hypercholesterolemia in Egypt

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

ClinicalTrials.gov processed this record on May 23, 2013