Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia (CEPHEUS)

This study has been completed.

Sponsor:

Collaborator:

ClinArt Company & Signen Clinical Discoveries

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01025388

First received: December 2, 2009

Last updated: February 7, 2013

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 2, 2009

Last Updated Date

February 7, 2013

Start Date ^ICMJE

November 2009

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01025388 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The proportion of patients 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). [ Time Frame: 6 months - One visit only, no follow up visits. ] [ Designated as safety issue: No ]
The proportion of patients reaching the LDL-C goals according to the Third Joint European Task Force guidelines / national guidelines, in the following 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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia

Official Title ^ICMJE

Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia

Brief 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, in the following sub-populations:

Primary/secondary prevention patients.
Patients with metabolic syndrome (according to NCEP III definition).

In addition, the purpose is 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

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

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: None Retained

Description:

Whole blood

Sampling Method

Non-Probability Sample

Study Population

Subject who visits the primary care clinics, cardiology clinics and internal medicine clinics, and who fulfil the inclusion criteria.

Condition ^ICMJE

Hypercholesterolemia

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

4053

Completion Date

May 2010

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Saudi Arabia

Administrative Information

NCT Number ^ICMJE

NCT01025388

Other Study ID Numbers ^ICMJE

NIS-SA-CRE-2009/1

Has Data Monitoring Committee

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

ClinArt Company & Signen Clinical Discoveries

Investigators ^ICMJE

Study Chair:	Prof. Mohammed Arafah	King Khalid University Hospital
Principal Investigator:	Dr. Shorook Alherz	King Fahad National Guard Hospital
Principal Investigator:	Dr. Khalid Alnemer	Security Forces Hospital
Principal Investigator:	Dr. Hossam Alghetany	Soliman Fakieh Hospital
Principal Investigator:	Dr. Othman Metwally	King Fahad General Hospital
Principal Investigator:	Dr. Akram Alkhadra	King Fahad University Hospital
Principal Investigator:	Dr. Faisal Alanizi	Ministry Of Health Saudi Arabia

Information Provided By

AstraZeneca

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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