HypercholesterolemiaCEPHEUSNCT01025388
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia
An observational study of Hypercholesterolemia, run by AstraZeneca at 5 sites in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 4,053 participants
- Where
- 5 sitesSaudi Arabia
- Study dates
- Nov 2009to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject who visits the primary care clinics, cardiology clinics and internal medicine clinics, and who fulfil the inclusion criteria.
Who may be able to join
- 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
Who cannot join
- Subjects who are unwilling or unable to provide informed consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Saudi Arabia5 sites
Research Site
Aljouf, North
Research Site
Dammam, Eastern Province
Research Site
Jeddah, Western
Research Site
Makah, Western
Research Site
Riyadh, Central
About this study
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).
Read more
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.
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, The study is focusing on the undertreatment of hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 6 months- One visit only, no follow up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 4,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinArt Company & Signen Clinical Discoveries
- Responsible party
- Sponsor
- Investigators
- Prof. Mohammed Arafah, Study chair, King Khalid University HospitalDr. Shorook Alherz, Principal investigator, King Fahad National Guard HospitalDr. Khalid Alnemer, Principal investigator, Security Forces HospitalDr. Hossam Alghetany, Principal investigator, Soliman Fakieh HospitalDr. Othman Metwally, Principal investigator, King Fahad General HospitalDr. Akram Alkhadra, Principal investigator, King Fahad University HospitalDr. Faisal Alanizi, Principal investigator, Ministry of Health, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025388
- Sponsor's protocol ID
- NIS-SA-CRE-2009/1
- Acronym
- CEPHEUS
- Status last verified
- May 2011
- First submitted
- 2 Dec 2009
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01025388
- Acronym / sponsor ID
- CEPHEUS / NIS-SA-CRE-2009/1
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, The study is focusing on the undertreatment of hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,053 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- ClinArt Company & Signen Clinical Discoveries
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject who visits the primary care clinics, cardiology clinics and internal medicine clinics, and who fulfil the inclusion criteria.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects who are unwilling or unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Mohammed Arafah study chair
King Khalid University Hospital
Dr. Shorook Alherz principal investigator
King Fahad National Guard Hospital
Dr. Khalid Alnemer principal investigator
Security Forces Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by AstraZeneca at 5 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 months- One visit only, no follow up visits.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2013.