HypercholesterolemiaCEPHEUSNCT01031277
Centralized Pan-Middle East Survey on the Under-treatment of Hypercholesterolemia, Sub-study for the Gulf States
An observational study of Hypercholesterolemia, run by AstraZeneca at 1 site in United Arab Emirates.
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, to establish the proportion of patients on lipid-lowering pharmacological treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 1,000 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Nov 2009to Jul 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: Inhabitants of Gulf States visiting their cardiologist for regular follow-up of their hypercholesterolaemia treatment
Who may be able to join
- Race
- 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
1 site in 1 country.
About this study
Official title: Centralized Gulf States Survey on the Undertreatment of Hypercholesterolemia
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, 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 in the following sub-populations:
- Primary/secondary prevention patients.
- Patients with metabolic syndrome (according to NCEP III definition). And 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, Update NCEP ATP111, Survey
- 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 (3)
Proportion patients on lipid-lowering drugs (LLD) reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III in subgroups: Primary/secondary prevention patients; Patients with metabolic syndrome ( NCEP III).
Measured: 6 months- One visit only, no follow up visits.
Proportion patients on LLD reaching the LDL-C goals according to the Third Joint European Task Force guidelines/national guidelines, in the survey population and in sub-populations: Primary/secondary prevention patients; Patients with metabolic syndrome.
Measured: 6 months- One visit only, no follow up visits.
To identify determinants (e.g. patient and physician characteristics, country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia.
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 posted14 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinart International
- Investigators
- Prof. Wael Al Mahmeed, Study chair, Shaikh Khalifa Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031277
- Sponsor's protocol ID
- NIS-GU-CRE-2009/1
- Other IDs
- SRP-CB-CRE-2006/01
- Acronym
- CEPHEUS
- Status last verified
- May 2011
- First submitted
- 11 Dec 2009
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Shehab A, Al-Rasadi K, Arafah M, Al-Hinai AT, Al Mahmeed W, Bhagavathula AS, Al Tamimi O, Al Herz S, Al Anazi F, Al Nemer K, Metwally O, Alkhadra A, Fakhry M, Elghetany H, Medani AR, Yusufali AH, Al Jassim O, Al Hallaq O, Baslaib FOAS, Alawadhi M, Amin H, Al-Hashmi K, Oulhaj A. The Management of Dyslipidaemia in Patients with Type 2 Diabetes Mellitus Receiving Lipid-Lowering Drugs: A Sub-Analysis of the CEPHEUS Findings. Curr Vasc Pharmacol. 2018;16(4):368-375. doi: 10.2174/1570161115666170705153815.
PubMed 28677510
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralized Gulf States Survey on the Undertreatment of Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01031277
- Acronym / sponsor ID
- CEPHEUS / NIS-GU-CRE-2009/1
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, Update NCEP ATP111, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Clinart International
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 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, 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 in the following sub-populations:
- Primary/secondary prevention patients.
- Patients with metabolic syndrome (according to NCEP III definition). And 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
- Inhabitants of Gulf States visiting their cardiologist for regular follow-up of their hypercholesterolaemia treatment
Key inclusion criteria (3 listed)
- Race
- 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.
3 secondary outcomes
Proportion patients on lipid-lowering drugs (LLD) reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III in subgroups: Primary/secondary prevention patients; Patients with metabolic syndrome ( NCEP III).
Time frame: 6 months- One visit only, no follow up visits.
Proportion patients on LLD reaching the LDL-C goals according to the Third Joint European Task Force guidelines/national guidelines, in the survey population and in sub-populations: Primary/secondary prevention patients; Patients with metabolic syndrome.
Time frame: 6 months- One visit only, no follow up visits.
To identify determinants (e.g. patient and physician characteristics, country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia.
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 25 May 2011.
- Derived from this study: PubMed 28677510Shehab A, Al-Rasadi K, Arafah M, Al-Hinai AT, Al Mahmeed W, Bhagavathula AS, Al Tamimi O, Al Herz S, Al Anazi F, Al Nemer K, Metwally O, Alkhadra A, Fakhry M, Elghetany H, Medani AR, Yusufali AH, Al Jassim O, Al Hallaq O, Baslaib FOAS, Alawadhi M, Amin H, Al-Hashmi K, Oulhaj A. The Management of Dyslipidaemia in Patients with Type 2 Diabetes Mellitus Receiving Lipid-Lowering Drugs: A Sub-Analysis of the CEPHEUS Findings. Curr Vasc Pharmacol. 2018;16(4):368-375. doi: 10.2174/1570161115666170705153815.
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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. Wael Al Mahmeed study chair
Shaikh Khalifa Medical City
1 site 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 1 site in United Arab Emirates.
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 3 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 25 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. 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?
On the ClinicalTrials.gov record for NCT01031277, which also lists 1 linked publication.
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 25 May 2011.