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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
  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. ] [ 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
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: 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
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 23, 2014