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

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ClinicalTrials.gov Identifier: NCT01604733
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : May 24, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease
Hypercholesterolemia

Detailed Description:
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia

Study Type : Observational
Actual Enrollment : 1000 participants
Time Perspective: Cross-Sectional
Official Title: Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia
Study Start Date : October 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
HYPERCHOLESTEROLEMIC PATIENTS



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Determinants (e.g. patient and physician characteristics , country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia [ Time Frame: 24 weeks ]
  4. Physician characteristics associated with the allocation of treatment regimen. [ Time Frame: 24 weeks ]
  5. 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 ]

Biospecimen Retention:   None Retained
blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01604733


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01604733     History of Changes
Other Study ID Numbers: NIS-EG-CRE-2010/01
First Posted: May 24, 2012    Key Record Dates
Last Update Posted: May 24, 2012
Last Verified: May 2012

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