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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:
ClinicalTrials.gov Identifier:
NCT01031277
First Posted: December 14, 2009
Last Update Posted: May 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Clinart International
Information provided by:
AstraZeneca
  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:


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. ]

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. ]
  • 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. ]
  • 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. ]

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

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
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
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): NCT01031277


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

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
First Submitted: December 11, 2009
First Posted: December 14, 2009
Last Update Posted: May 25, 2011
Last Verified: May 2011

Keywords provided by AstraZeneca:
Hypercholesterolemia
Update NCEP ATP111
Survey

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