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Centralized Pan-Middle East Survey on the Under-treatment of Hypercholesterolemia, Sub-study for the Gulf States (CEPHEUS)

This study has been completed.
Sponsor:
Collaborator:
ClinArt International Company
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01031277
First received: December 11, 2009
Last updated: May 24, 2011
Last verified: May 2011
History of Changes
  Purpose

The purpose of the study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III guidelines, overall and by country, to establish the proportion of patients on lipid-lowering pharmacological 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.

  • Patients with metabolic syndrome (according to NCEP III definition). And to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines/national guidelines, in the survey population and in the following sub-populations:

    • Primary/secondary prevention patients.
    • Patients with metabolic syndrome.

Condition
Hypercholesterolemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Centralized Gulf States Survey on the Undertreatment of Hypercholesterolemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III guidelines, overall and by country. [ Time Frame: 6 months- One visit only, no follow up visits. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion patients on lipid-lowering drugs (LLD) reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III in subgroups: Primary/secondary prevention patients; Patients with metabolic syndrome ( NCEP III). [ Time Frame: 6 months- One visit only, no follow up visits. ] [ Designated as safety issue: No ]
  • Proportion patients on LLD reaching the LDL-C goals according to the Third Joint European Task Force guidelines/national guidelines, in the survey population and in sub-populations: Primary/secondary prevention patients; Patients with metabolic syndrome. [ Time Frame: 6 months- One visit only, no follow up visits. ] [ Designated as safety issue: No ]
  • To identify determinants (e.g. patient and physician characteristics, country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia. [ Time Frame: 6 months- One visit only, no follow up visits. ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Whole blood


Estimated Enrollment: 1000
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  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

Inhabitants of Gulf States visiting their cardiologist for regular follow-up of their hypercholesterolaemia treatment

Criteria

Inclusion Criteria:

  • Race
  • On lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.
  • Subject must sign informed consent

Exclusion Criteria:

  • Subjects who are unwilling or unable to provide informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031277

Locations
United Arab Emirates
Research Site
Abu Dhabi, United Arab Emirates
Sponsors and Collaborators
AstraZeneca
ClinArt International Company
Investigators
Study Chair: Prof. Wael Al Mahmeed Shaikh Khalifa Medical City
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca Gulf States
ClinicalTrials.gov Identifier: NCT01031277     History of Changes
Other Study ID Numbers: NIS-GU-CRE-2009/1, SRP-CB-CRE-2006/01
Study First Received: December 11, 2009
Last Updated: May 24, 2011
Health Authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi

Keywords provided by AstraZeneca:
Hypercholesterolemia
Update NCEP ATP111
Survey

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

ClinicalTrials.gov processed this record on May 19, 2013