NCT01025388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,053

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 8, 2013

Status Verified

May 1, 2011

Enrollment Period

6 months

First QC Date

December 2, 2009

Last Update Submit

February 7, 2013

Conditions

Hypercholesterolemia

Keywords

HypercholesterolemiaThe study is focusing on the undertreatment of hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • 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).

    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.

    6 months- One visit only, no follow up visits.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Subjects who are unwilling or unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Riyadh, Central, Saudi Arabia

Location

Research Site

Dammam, Eastern Province, Saudi Arabia

Location

Research Site

Aljouf, North, Saudi Arabia

Location

Research Site

Jeddah, Western, Saudi Arabia

Location

Research Site

Makah, Western, Saudi Arabia

Location

Biospecimen

Retention: NONE RETAINED

Whole blood

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Prof. Mohammed Arafah

    King Khalid University Hospital

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

November 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

February 8, 2013

Record last verified: 2011-05

Locations

SA(5)