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
  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, 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.

Condition
Hypercholesterolemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Centralized Pan-Middle East 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:
  • 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 ]

Biospecimen Retention:   None Retained

Whole blood


Enrollment: 4053
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 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

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

Criteria

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.
  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: NCT01025388

Locations
Saudi Arabia
Research Site
Riyadh, Central, Saudi Arabia
Research Site
Dammam, Eastern, Saudi Arabia
Research Site
Aljouf, North, Saudi Arabia
Research Site
Jeddah, Western, Saudi Arabia
Research Site
Makah, Western, Saudi Arabia
Sponsors and Collaborators
AstraZeneca
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01025388     History of Changes
Other Study ID Numbers: NIS-SA-CRE-2009/1
Study First Received: December 2, 2009
Last Updated: February 7, 2013
Health Authority: Saudi Arabia: Ministry of Health

Keywords provided by AstraZeneca:
Hypercholesterolemia
The study is focusing on the undertreatment of hypercholesterolemia

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

ClinicalTrials.gov processed this record on October 19, 2014