Clinical trial NCT01025388: Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia
Official title: Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
The study is focusing on the undertreatment of hypercholesterolemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: ClinArt Company & Signen Clinical Discoveries
First posted: 2009-12-03
Enrollment: 4053
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 6 months- One visit only, no follow up visits.
Secondary outcomes:
measure: 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).
timeFrame: 6 months - One visit only, no follow up visits.
measure: 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.
timeFrame: 6 months- One visit only, no follow up visits.
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Research Site
state: Central
city: Dammam
country: Saudi Arabia
facility: Research Site
state: Eastern
city: Aljouf
country: Saudi Arabia
facility: Research Site
state: North
city: Jeddah
country: Saudi Arabia
facility: Research Site
state: Western
city: Makah
country: Saudi Arabia
facility: Research Site
state: Western
Study officials:
affiliation: King Khalid University Hospital
name: Prof. Mohammed Arafah
role: STUDY_CHAIR
affiliation: King Fahad National Guard Hospital
name: Dr. Shorook Alherz
role: PRINCIPAL_INVESTIGATOR
affiliation: Security Forces Hospital
name: Dr. Khalid Alnemer
role: PRINCIPAL_INVESTIGATOR
affiliation: Soliman Fakieh Hospital
name: Dr. Hossam Alghetany
role: PRINCIPAL_INVESTIGATOR
affiliation: King Fahad General Hospital
name: Dr. Othman Metwally
role: PRINCIPAL_INVESTIGATOR
affiliation: King Fahad University Hospital
name: Dr. Akram Alkhadra
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health, Saudi Arabia
name: Dr. Faisal Alanizi
role: PRINCIPAL_INVESTIGATOR
References: