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

Hypercholesterolemia Clinical Trial

— CEPHEUS  

Official title:

Centralized Gulf States Survey on the Undertreatment of Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031277
• Other study ID #: NIS-GU-CRE-2009/1
• Secondary ID: SRP-CB-CRE-2006/
• Status: Completed
• Phase: N/A
• First received: December 11, 2009
• Last updated: May 24, 2011
• Start date: November 2009
• Est. completion date: July 2010

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypercholesterolemia

Locations

Country	Name	City	State
United Arab Emirates	Research Site	Abu Dhabi

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Clinart International

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months- One visit only, no follow up visits.	No
Secondary	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).		6 months- One visit only, no follow up visits.	No
Secondary	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.		6 months- One visit only, no follow up visits.	No
Secondary	To identify determinants (e.g. patient and physician characteristics, country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia.		6 months- One visit only, no follow up visits.	No