HypercholesterolemiaCEPHEUSNCT01604733
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia
An observational study of Hypercholesterolemia, run by AstraZeneca.
Trial summary
Study objective is to evaluate the level of control of hypercholesterolemia in Egypt in patients taking lipid lowering agents for at least 3 months ( with no drug change or dose amendment for a minimum of 6 weeks). 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
- No sites listed yet
- Study dates
- Oct 2010to Jun 2011
- 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: Community patients
Who may be able to join
- 18 years and above on current lipid lowering drug for at least 3 months with no dose change for a minimum of 6 weeks
- Subject must provide informed consent and comply with the survey procedures
Who cannot join
- Less than 18 years less than 3 months on antidyslipidemic agent Subjects who are unwilling or unable to provide informed consent
About this study
Study objective is to evaluate the level of control of hypercholesterolemia in Egypt in patients taking lipid lowering agents for at least 3 months ( with no drug change or dose amendment for a minimum of 6 weeks).
Read the detailed description
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia
- Conditions
- Hypercholesterolemia
- Keywords
- Multi-Center Survey, patients currently on lipid-lowering pharmacological treatment, level of Control of Hypercholesterolemia in Egypt
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HYPERCHOLESTEROLEMIC PATIENTS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , overall and by country
Measured: 24 weeks
Secondary outcomes (5)
The proportion of patients on lipid-lowering 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 and with metabolic syndromes
Measured: 24 weeks
The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the Third Joint European Task Force guideline, in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes
Measured: 24 weeks
Determinants (e.g. patient and physician characteristics , country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia
Measured: 24 weeks
Physician characteristics associated with the allocation of treatment regimen.
Measured: 24 weeks
The proportion of patients on lipid-lowering treatment reaching the non HDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the sub-population patients with fasting triglycerides<200 mg/d
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2011
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
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohie E Sherif, MD, Study chair, Ethical committee, Faculty of medicine, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604733
- Sponsor's protocol ID
- NIS-EG-CRE-2010/01
- Acronym
- CEPHEUS
- Status last verified
- May 2012
- First submitted
- 21 May 2012
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. 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
- NCT01604733
- Acronym / sponsor ID
- CEPHEUS / NIS-EG-CRE-2010/01
- Conditions
- Hypercholesterolemia
- Keywords
- Multi-Center Survey, patients currently on lipid-lowering pharmacological treatment, level of Control of Hypercholesterolemia in Egypt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 May 2012 (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.
Study objective is to evaluate the level of control of hypercholesterolemia in Egypt in patients taking lipid lowering agents for at least 3 months ( with no drug change or dose amendment for a minimum of 6 weeks).
Detailed description
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HYPERCHOLESTEROLEMIC PATIENTS | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community patients
Key inclusion criteria (2 listed)
- 18 years and above on current lipid lowering drug for at least 3 months with no dose change for a minimum of 6 weeks
- Subject must provide informed consent and comply with the survey procedures
Key exclusion criteria (1 listed)
- Less than 18 years less than 3 months on antidyslipidemic agent 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
The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , overall and by country
Time frame: 24 weeks
5 secondary outcomes
The proportion of patients on lipid-lowering 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 and with metabolic syndromes
Time frame: 24 weeks
The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the Third Joint European Task Force guideline, in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes
Time frame: 24 weeks
Determinants (e.g. patient and physician characteristics , country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia
Time frame: 24 weeks
Physician characteristics associated with the allocation of treatment regimen.
Time frame: 24 weeks
The proportion of patients on lipid-lowering treatment reaching the non HDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the sub-population patients with fasting triglycerides<200 mg/d
Time frame: 24 weeks
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 24 May 2012.
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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.
Mohie E Sherif, MD study chair
Ethical committee, Faculty of medicine, Alexandria University
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by AstraZeneca.
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 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , overall and by country (time frame: 24 weeks). 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 24 May 2012.