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
  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:


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
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: 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 July 24, 2014