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

February 7, 2013 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

4053

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Central
      • Riyadh, Central, Saudi Arabia
        • Research Site
    • Eastern
      • Dammam, Eastern, Saudi Arabia
        • Research Site
    • North
      • Aljouf, North, Saudi Arabia
        • Research Site
    • Western
      • Jeddah, Western, Saudi Arabia
        • Research Site
      • Makah, Western, Saudi Arabia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
6 months- One visit only, no follow up visits.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
6 months - One visit only, no follow up visits.
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.
6 months- One visit only, no follow up visits.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

ClinArt Company & Signen Clinical Discoveries

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-SA-CRE-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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